Infectious diseases

People in hotel quarantine need Increased psychological support and other mental health services

Michael Dinh · Owen Hutchings · Kendall Bein · James Shaw · Aditi Raut · Saartje Berendsen Russell · Dianna Jagers · Rajip Thapa · Gregory Fox · James Edwards · Timothy Wand · Warwick Britton

Influenza vaccine uptake in children has grown in response to increased awareness and progressive expansion of funding Over the past decade, multiple initiatives have been implemented to strengthen influenza vaccination programs in Australia, with an increasing focus on children. In this article, we review these changes, the events that prompted them, and how they have influenced influenza vaccine uptake in Australia. Burden of influenza Before the coronavirus disease 2019 (COVID‐19) pandemic, influenza was responsible for a higher disease burden and overall health impact than any other vaccine‐preventable disease in Australia.1 Historically, Australian influenza notification rates have been highest in children, particularly in those aged less than 2 years.2 The highest annual hospitalisation rates for influenza overall have been recorded in children aged less than 6 months (192 per 100 000 per year), followed by children aged 6–23 months (109 per 100 000 per year).2 Although paediatric hospitalisation rates are high, annual rates of influenza‐associated deaths in children are low compared with adults: 0.20–0.39 per 100 000 children aged under 5 years compared with 0.65 per 100 000 in people aged 65–74 years and 3.66 per 100 000 in people aged 75 years or more.2 While it appears that influenza may have become more burdensome for children in recent years due to an increase in disease notifications (Box 1), the notification rates also reflect an increase in influenza testing rates. For example, in New South Wales, there was a seven‐fold increase in tests done in 2019 compared with 2009.3 However, influenza notifications dramatically declined in 2020 in all age groups (Box 1), most likely due to increased hygiene and physical distancing measures and the implementation of border closures to reduce transmission of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) — the virus that causes COVID‐19. Influenza‐associated morbidity and mortality rates also likely underestimate the true influenza‐associated burden related to underascertainment bias and other factors. Influenza vaccination recommendations and funding All people in Australia aged 6 months or more are recommended to receive annual influenza vaccination, with free influenza vaccines for the highest risk groups provided by the National Immunisation Program (NIP).4 Vaccination is only contraindicated for people who have experienced anaphylaxis in association with a previous dose or any component of an influenza vaccine.4 Children aged 6 months to 9 years receiving the vaccine for the first time require two doses at least 4 weeks apart; those aged 9 years or more require only one dose in their first year of receipt.4 Until recently, there was limited funding for, and promotion of, influenza vaccination in children. In 2018, following the large 2017 influenza season (Box 1), and underpinned by evidence of paediatric disease burden, vaccine safety and efficacy,2,6,7 all Australian states and territories, except the Northern Territory, followed Western Australia’s 2008 initiative in funding influenza vaccination for all children aged 6–59 months; the NT followed in 2019 (Box 2). The NIP expanded in 2019 to include Aboriginal and Torres Strait Islander peoples of all ages (closing the funding gap for those aged 5 to < 15 years), and in 2020, the influenza vaccine was added to the NIP for all children aged 6–59 months.5 Influenza vaccine effectiveness Influenza vaccine effectiveness is usually measured against either all laboratory‐confirmed influenza (using disease notification data) or influenza‐associated hospitalisation (a proxy for severe disease) and varies each year. In 2015, influenza vaccine effectiveness in children aged under 18 years estimated from data collected from sentinel general practitioner networks was 54%,8 indicating that influenza‐associated primary care visits more than halved in vaccinated children compared with unvaccinated children. In 2017, a year dominated by the influenza A subtype H3N2, for which the vaccine typically performs less well, the influenza vaccine effectiveness against hospitalisation for influenza was estimated to be 30% in children;6 however, in 2018, an influenza A subtype H1N1 predominant year, vaccine effectiveness against paediatric influenza hospitalisation was 78%.9 Despite moderate effectiveness, at an individual and population level, influenza vaccination still prevents significant morbidity and mortality. For example, with 55% of population coverage and an adjusted vaccine effectiveness of only 32% (95% CI, 16–44%) for children aged 5–17 years during the 2017–2018 influenza season in the United States, vaccination was still estimated to have prevented 1.4 million illnesses, 711 000 medical visits, 3700 hospitalisations, and 89 deaths of children aged 5–17 years.10 Influenza vaccine safety In April 2010, early in the Australian influenza vaccination season, the Australian Government’s Chief Medical Officer suspended the use of influenza vaccine in children aged 5 years or less due to an unexpectedly high rate of fever and febrile seizures in the 4–24 hours following influenza vaccine administration.11 Influenza vaccination in children aged 5 years or less continued with non‐CSL influenza vaccines from August 2010 onwards,12 given they had no safety issues. The program suspension had negative effects on influenza vaccine attitudes, confidence and coverage in children in the following years.13 However, recent evidence suggests that influenza vaccine safety concerns may no longer be a significant barrier to influenza vaccination of children in Australia. Rather, significant barriers include a lack of recommendation from a health care provider, difficulties in either remembering to make or getting an appointment for vaccination, a general lack of support for influenza vaccination, or a lack of history of influenza vaccine uptake by the child or their parent.14 An independent review into the national response to the Fluvax (CSL) safety incident identified ways to strengthen the safe delivery of influenza (and other) vaccines in Australia.15 In response to these recommendations, a national sentinel vaccine active safety surveillance system, known as AusVaxSafety (www.ausvaxsafety.org.au) was established in 2014. In this system, people of all ages who receive an influenza vaccine (or their carers) at more than 350 participating sentinel clinics (as at March 2021) are sent a short message service (SMS) text message and/or email in the days after vaccination with questions on whether they or their child experienced an adverse event following immunisation.7 Overall, data from this system have shown a safety profile consistent with that expected from clinical trials for all vaccine brands: approximately 10% of children’s carers report an adverse event following immunisation in their child within 3 days of influenza vaccination, the most common being fever or pain, swelling or redness at the injection site.7 Data from this ever‐expanding vaccine safety monitoring system have consistently shown low and expected reporting rates of mild transient adverse events known to be associated with the influenza vaccine. Recorded influenza vaccine uptake Since 2007, the number of influenza vaccine doses distributed and the recorded population coverage have increased in Australia, but with fluctuating uptake in children. Following the rapid attainment of high coverage in Western Australia in both Aboriginal and Torres Strait Islander and non‐Aboriginal children aged 6–59 months from 2008, coverage decreased substantially after the 2010 safety incident (Box 3 and Box 4). Coverage in Aboriginal and Torres Strait Islander children increased after the NIP funding in 2015, with highest rates in the NT (55.8%) in 2015 (Box 3). Coverage also increased dramatically in non‐Aboriginal children in 2018 (Box 4) following the introduction of state‐ and territory‐based programs for all children aged 6–59 months. In 2020, the first year of NIP‐funding for children aged 6–59 months, the reported uptake was 43.9%.16 This estimate may be higher given the uptake was calculated using doses recorded between March and August 2020 (rather than a full 12‐month period),16 and overall, actual coverage is likely higher due to issues of under‐reporting to the Australian Immunisation Register.17 The number of influenza vaccine doses available around Australia for all ages has also increased, with 8.3 million distributed in 2017, to 18 million in 2020.18 While a 43.9% uptake in children aged 6–59 months in 2020 in Australia represents an improvement from past low vaccination rates, Australia needs strategies to improve and sustain high coverage. These could include personalised vaccination reminders19 and provision of greater access to influenza vaccination services.20 Furthermore, given the influence of a recommendation from a health care provider on vaccine uptake,14 implementing a combination of education, communication training, electronic prompts and standing order protocols21 may assist health care providers in recommending influenza vaccination to all patients. Mandatory reporting of vaccination data to the Australian Immunisation Register, recently implemented in the context of the COVID‐19 vaccine roll‐out in Australia and extended to include other vaccines,22 should also assist in ensuring more accurate vaccine coverage estimations of influenza and all vaccines. Conclusion Influenza vaccine uptake in young children in Australia has increased in response to the progressive expansion of funding and is now delivered under the NIP. Further gains in uptake should ensure that protection against influenza disease in children is optimised during the ongoing COVID‐19 pandemic and in years to come. Box 1 – Notification rates of laboratory‐confirmed influenza in children aged less than 5 years in Australia, 2007–2020* * Influenza testing rates also increased over this time period.3 Source: National Notifiable Diseases Surveillance System, as at 18 February 2021. Box 2 – Significant events in influenza disease and vaccination policy in Australia ACT = Australian Capital Territory; NSW = New South Wales; NT = Northern Territory; QLD = Queensland; SA = South Australia; TAS = Tasmania; VIC = Victoria; WA = Western Australia; QIV = quadrivalent influenza vaccine. * Vaccine funded for Aboriginal and Torres Strait Islander people aged 15 years or more since 1999 (for all Aboriginal and Torres Strait Islander people aged ≥ 50 years, and Aboriginal and Torres Strait Islander people aged 15–49 years who have at least one of a range of underlying medical conditions that increase their risk of influenza or complications). Source: National Centre for Immunisation Research and Surveillance.5 Box 3 – Trends in recorded coverage of any dose of seasonal influenza vaccine among Aboriginal and Torres Strait Islander children aged 6 months to less than 5 years, by jurisdiction, 2007–2019 ACT = Australian Capital Territory; NSW = New South Wales; NT = Northern Territory; QLD = Queensland; SA = South Australia; TAS = Tasmania; VIC = Victoria; WA = Western Australia. Source: Australian Immunisation Register, data as at 31 March 2020. Box 4 – Trends in recorded coverage of any dose of seasonal influenza vaccine among non‐Aboriginal children aged 6 months to less than 5 years, by jurisdiction, 2007–2019 ACT = Australian Capital Territory; NSW = New South Wales; NT = Northern Territory; QLD = Queensland; SA = South Australia; TAS = Tasmania; VIC = Victoria; WA = Western Australia. Source: Australian Immunisation Register, data as at 31 March 2020.

Samantha J Carlson · Christopher C Blyth · Frank H Beard · Alexandra J Hendry · Allen C Cheng · Helen E Quinn · Julie Leask · Kristine Macartney

A lack of clear protocols elevates risks for clinicians for the consequences of decisions that they have a professional duty to make in the interests of their community Clinicians, ethicists and lawyers have long debated the parameters of triage in response to the inevitable disasters that sporadically overwhelm the health care system. Almost universally, they have advocated for open, transparent and consultative triage protocols, guidelines and legislation to combat biases and to support clinicians making unavoidable decisions in the interests of the community as a whole. The coronavirus disease 2019 (COVID‐19) pandemic has highlighted the importance of transparent triage. While there is considerable debate about ethical aspects of triage protocols, including concerns that the traditional focus on utilitarianism is discriminatory, largely missing from this discussion in Australia is that triage protocols are also important from a legal perspective — as a mechanism to promote lawful decision‐making processes and as a justification or defence to support clinicians’ decisions if a matter is litigated. The purpose of this article is twofold. First, after providing an overview of current COVID‐19 triage policies in Australia, we assess their legal status. Second, we argue that beyond ethics, transparent policies are needed so their compliance with law can be tested, and to enable practitioners to better understand their obligations before making sometimes “impossible” decisions. Australian COVID‐19 triage policies Australian clinicians have seen numerous ethical and professional guidance documents addressing COVID‐19 triage.1,2,3 These documents anticipate that if Australia’s health care system is overwhelmed as in other countries, clinicians will need guidelines to allocate limited resources, including ventilators, beds and highly trained personnel. The umbrella term “triage policy” denotes: (i) broad ethical or operational guidelines with suggested decision‐making principles;1,2,3 and (ii) more specific triage protocols,4 with set inclusion and exclusion criteria, and a process to prioritise individual patients when the system is overwhelmed. Many Australian COVID‐19 triage policies are ethical guidelines, but some Australian hospitals have also developed triage protocols.5 Internationally, the availability and content of such protocols varies widely. In a study from the United States, over half of responding institutions lacked a COVID‐19 triage protocol.6 In 2020, Mitchell and colleagues exposed insufficient transparency and significant variation in Victorian protocols.5 In Australia, primary responsibility for the administration of hospital services lies with the states, which have the power to promote a statewide approach to triage. Although every Australian state and territory has disaster management plans,7 publicly available COVID‐19 triage protocols are lacking. From March 2020 to 27 November 2020, the lead author (EC) regularly searched health department websites for COVID‐19 triage policies, examining both the websites’ content dedicated to COVID‐19 and searching keywords alone and in various combinations (COVID; intensive care; critical care; ICU; triage; framework; guidelines; policy; ethical). These searches revealed few relevant documents (Box 1). New South Wales is the only state to mention a triage guideline, but its COVID‐19 framework does not link to it.8 Queensland Health released an extensive ethical framework for COVID‐19 in April 2020,5 which has since been removed.9 Western Australia has a four‐page ethical framework but no publicly accessible protocol.10 The Commonwealth Government’s COVID‐19 strategy indicates the Commonwealth will work with state and territory governments to “agree on novel coronavirus triage criteria (if required)”,11 but there are no such criteria to date. Given constitutional arrangements, there is no expectation that the Commonwealth Government would provide these. The National Health and Medical Research Council has conducted consultation on an ethics framework for pandemics, but this is limited to ethical guidance. Legal status of COVID‐19 triage policies The prospect of deciding between patients who would benefit from life‐sustaining treatment is distressing. Compounding this is the potential for legal liability. Many of the legal issues that arise in pandemic triage are untested, and various areas of law may be engaged and applied in complex, fact‐specific ways. As other work has detailed, health authorities have wide discretion in making resource allocation decisions, which are generally respected by the courts.12,13 However, in some circumstances, clinicians (and institutions) may be found liable, and decisions may also be challenged on public law grounds (Box 2).13,14,15 These concerns are not merely academic; after Hurricane Katrina one doctor faced possible murder charges and civil lawsuits after several patients died during a hospital evacuation.16 Overseas, some governments have enacted immunity or indemnity laws to protect clinicians making COVID‐19 triage decisions.14,15 No such laws exist in Australia, and they do not appear to have been considered. Absent such laws, triage protocols may provide the next strongest legal defence. Under civil liability legislation, a clinician will generally not be negligent if acting in a manner widely accepted in Australia by peer professional opinion as competent medical practice (professional practice defence).12,13 Concrete advice on the legal significance of triage policies is difficult because the relationship between law and professional guidance is complex and each case is evaluated according to its unique facts. Whether the professional practice defence applies generally depends on the guideline’s nature, author and purported authority.17,18 A policy may create additional obligations beyond those imposed by law (eg, a specific hospital COVID‐19 triage protocol that must be followed by its clinicians), which may inform the legal standard of care.18 However, policy is not necessarily determinative of the standard of care, especially when couched as broad guidance (eg, COVID‐19 ethical guidelines from a professional college).18 Rigid adherence to policy can also be problematic; to meet the standard of care (and broader public decision‐making standards), clinicians must use judgment appropriate to the circumstances.17 Moreover, while policy can establish obligations in addition to the law, law may also impose more onerous obligations than a policy.18 When this occurs the legal standard will prevail. In other words, COVID‐19 triage policies can shape a regulatory response but only within the boundaries of the law. COVID‐19 triage policies may infringe laws in various nuanced ways.14 Liddell and colleagues note that the utilitarian “save the most lives possible” principle underlying most triage policies can infringe patients’ legal rights, many of which are unchanged in a disaster.14 In the United Kingdom, a legal challenge to the National Institute for Health and Care Excellence (NICE) COVID‐19 critical care protocol was initiated on the basis that its heavy reliance on the Clinical Frailty Scale constituted unlawful discrimination.19 In response, NICE revised the protocol to reduce reliance on the Clinical Frailty Scale for some patients. These issues have significant implications for clinicians: Absent a COVID‐19 triage policy, not providing beneficial life‐sustaining treatment is potentially risky because it may be harder to establish the professional practice defence in a negligence action. An institution’s failure to promulgate a policy could also result in claims. Additionally, a triage protocol (with its greater degree of specificity) would generally provide more legal protection than ethical guidelines. While it is lawful for governments and professional bodies to issue COVID‐19 triage policies, these policies should rely on appropriate evidence and must comply with specific jurisdictional laws, such as guardianship and human rights legislation (Box 2). Triage policies promote quality and consistency in decision making and guide clinicians to consider appropriate factors. However, clinicians must still exercise judgment which is reasonable and responsive to individual circumstances. Policies should provide guidance for when an individual is denied life‐sustaining treatment, since the duty to exercise reasonable care remains. Where reasonably possible, this may include communicating to the patient (or family) the reasons for the decision, providing appropriate palliative care, and information about complaints or dispute resolution processes. Transparency — not just about ethics From an ethical perspective, legitimate triage decisions require “accountability for reasonableness” — a fair process based on relevant criteria, a publicly accessible rationale, and (to the extent possible given the urgency of decisions) mechanisms for appeal, review and enforcement.20 Transparency is also important from a legal perspective because it subjects triage policies to public scrutiny before public health emergencies reach crisis levels. While internal legal advice on triage policies may have been sought, the NICE example illustrates that public scrutiny, consultation and litigation play an important role in testing legal boundaries. In addition to protecting individual patients, this promotes rigorous policy development and evaluation, and also benefits clinicians who are then not relying on policy later found to be deficient.17 It may also alleviate stress caused by uncertainty about protocols. Disclosure of triage policies also delivers a measure of natural justice by providing notice to patients and their families of decision‐making criteria and processes. Conclusion So far, Australia has avoided the scale of pandemic that has overwhelmed health systems elsewhere. While in this context, governments’ reluctance to develop and/or release triage protocols until a crisis has arrived is politically understandable, such a course of action carries significant risks. Public confidence is enhanced when governments have the political courage to embark on these difficult public debates in advance of need. Prioritising some individuals over others when the demand for resources exceeds supply is confronting for clinicians and the community alike, and challenges us to reflect on our deeply held values as a society. When clinicians are allocating scarce resources, they need standards to support their decisions which have been subject to public consultation and rigorous legal review. Australia’s successful management of the COVID‐19 pandemic is offering us the luxury of time to consult and reflect. [Corrections added on 9 June 2021 after first online publication: an additional row was added to Box 1.] Box 1 – Australian triage protocols and ethical guidelines for resource allocation during the coronavirus disease 2019 (COVID‐19) pandemic Jurisdiction COVID‐19 triage protocol or ethical guidelines Type of guidance Publicly available Commonwealth Australian Health Ethics Committee of the National Health and Medical Research Council: An ethics framework for pandemics (in development). Ethical guidelines Anticipated Australian Capital Territory None located on ACT Health website (https://health.act.gov.au). New South Wales NSW Health provides a COVID‐19 framework entitled “NSW adult intensive care services pandemic response planning”.8 The framework indicates that the NSW guideline for resource‐based decision making includes the “use of allocation frameworks and tools” with a reference (but no link to) a document entitled the “NSW Health COVID‐19 intensive care guidance drawn from principles in the NSW Health Influenza Pandemic Plan (PD2016_016). Sydney: NSW Health; 2020”. This 2020 document is based on the NSW Health Influenza Pandemic Plan (PD2016_016), which references the NSW Health policy “Influenza Pandemic – Providing Critical Care (PD2010_028)”. PD2010_028 contains a triage tool (https://www1.health.nsw.gov.au/pds/Pages/a-z.aspx). However, as the updated COVID‐19 intensive care guidance is not publicly available, we cannot confirm that it contains the same guidance as PD2016_016 or the PD2010_028 triage tool. Triage protocol and ethical and operational guidelines No Northern Territory None located on the NT Health Department website (https://health.nt.gov.au). Queensland On 20 April 2020, Queensland Health released a comprehensive ethical framework (developed in consultation with numerous stakeholders) but this has since been removed from its website.9 Ethical guidelines No (initially available but subsequently recalled) South Australia None located on the SA Health website (https://www.sahealth.sa.gov.au). Tasmania None located on the Tasmanian Department of Health website (https://www.health.tas.gov.au). Victoria None located on the Victorian Department of Health and Human Services website (https://www.dhhs.vic.gov.au/clinical-guidance-and-resources-covid-19). Western Australia The WA Health Department website includes a framework to guide decision making on the appropriateness of intensive care management during the COVID‐19 pandemic (last updated 26 June 2020) in its section on COVID‐19 guidance for health professionals.10 Ethical guidelines Yes Box 2 – Examples of potential areas of legal risk in response to pandemic triage decisions* Civil law Withholding or withdrawing beneficial life‐sustaining treatment from one patient to provide it to a patient with a better prognosis could amount to a breach of the duty of care and liability in negligence (subject to the peer professional practice defence for clinicians and the resource allocation defence in the case of hospitals). Criminal law Withdrawing a ventilator from one patient who is stable to provide it to another patient with a greater chance of survival could lead to charges of murder or manslaughter if the first patient dies as a result (charges would be subject to prosecutorial discretion and jurisdiction‐specific defences such as necessity). Commonwealth and state antidiscrimination laws A triage protocol could violate state and territory antidiscrimination legislation if the decision was made on the basis of a protected attribute such as age, disability or race (although specific protections may apply under the legislation for decision makers). Guardianship legislation This applies to patients who lack decision‐making capacity; for example, because they are unconscious, sedated or have cognitive impairment. At common law, medical practitioners have no legal duty to provide treatment that is non‐beneficial. However, the Guardianship and Administration Act 2000 (Qld) makes it an offence to withhold or withdraw life‐sustaining treatment from patients who lack capacity without the consent of an appropriate decision maker, even if providing that treatment would be “inconsistent with good medical practice” (ie, even if that treatment is non‐beneficial). This may preclude some triage decisions in Queensland. A decision to withhold or withdraw beneficial life‐sustaining treatment from a patient who lacks capacity to provide it to someone with a better prognosis may violate state or territory guardianship legislation, which requires health care decisions to be made in a person’s best interests. (This could also result in an emergency application to the Supreme Court to intervene in its parens patriae jurisdiction to protect the patient’s best interests.) * This is a non‐exhaustive list of examples. For an expanded discussion of legal challenges in Australia, see Close et al.13 See further Liddell et al14 for the UK context, which has some similarities to Australia.

Eliana Close · Lindy Willmott · Tina Cockburn · Simon Young · Will Cairns · Ben P White

Characterising the care requirements of patients with coronavirus disease 2019 (COVID‐19) is essential for resource allocation.1 Knowledge of care needs is based predominantly on experience in regions where health care capacity has been strained, and may not reflect ideal practice.2,3 We therefore examined COVID‐19 testing data for South Australia, the care requirements of patients with confirmed COVID‐19, and the disposition of people with potential COVID‐19 who presented to the designated COVID‐19 hospital for SA, the Royal Adelaide Hospital (RAH), during a period of low COVID‐19 prevalence and limited community transmission (30 January – 26 April 2020). We analysed SA Pathology data on tests for severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) and other respiratory pathogens, and clinical data from hospital electronic health records (further details: online Supporting Information). The Central Adelaide Local Health Network Human Research Ethics Committee approved the study, and waived the requirement for patient consent (reference, 13091). Of 52 883 people tested in SA for SARS‐CoV‐2, 438 had polymerase chain reaction (PCR)‐confirmed infections (0.8%); their median age was 54 years (interquartile range [IQR], 31–64 years; range, 1–94 years), and 211 were female (48%). The median age of screened people with negative results was 43 years (IQR, 28–60 years; range, 0–104 years), of whom 30 380 were female (58%). Seventeen people with confirmed COVID‐19 (3.9%) and 7588 of those without COVID‐19 (14%) were also positive for another respiratory pathogen (Supporting Information, table 1). There were no cases of COVID‐19 among people in high care nursing facilities or prisons, nor among homeless people; one infection of a health care worker caring for people with COVID‐19 was recorded in Adelaide. The number of patients admitted to the RAH with COVID‐19 broadly paralleled that of new cases in SA, but intensive care unit (ICU) occupancy peaked (6/7 April) and the number of people screened in the RAH emergency department for COVID‐19 declined (from 17 April) after the peak in new cases (21 March) (Box 1). The median time from diagnosis to viral clearance (according to national guidelines4) was 15 days (IQR, 12–19 days); it was lower for people managed in the community (14 days; IQR, 11–17 days) than for those admitted to hospital (17 days; IQR, 13–22 days), and there were no sex‐ or age‐related differences (data not shown). A total of 285 people with confirmed COVID‐19 (227 aged 18–65 years; 58 over 65 years) were managed entirely in the community (Box 2); their age and sex distributions were similar to those of all SARS‐CoV‐2‐positive people (data not shown). Of 18 228 patients who presented to the RAH emergency department, 2327 (12.8%) met screening criteria for potential COVID‐19, of whom 120 (5.2%) proved to be SARS‐CoV‐2‐positive (new diagnoses in 19 people) (Supporting Information, figure). Among people who met the criteria for potential COVID‐19, a larger proportion of people with positive results than of those with negative results arrived by private vehicle (59 [49%] v 797 [36%]), and smaller proportions required resuscitation (one [0.8%] v 72 [3%]) or had conditions deemed imminently life‐threatening (14 [12%]) v 706 [32%]); among people over 65 years, two of 37 SARS‐CoV‐2‐positive people (5%) and 406 of 939 SARS‐CoV‐2‐negative people (43%) required resuscitation or emergency review. Most people with confirmed infections were admitted to the inpatient COVID‐19 unit (90 [75%] v 419 with negative results [19%]), while three SARS‐CoV‐2‐positive (2%) and 79 SARS‐CoV‐2‐negative people (4%) were admitted from the emergency department to the ICU (Supporting Information, table 2). One of 18 228 people who presented to the ED did not meet screening criteria for potential COVID‐19 but subsequently tested positive (screening failure rate, 0.005%). A total of 536 patients were admitted to the inpatient COVID‐19 unit, including 117 who were SARS‐CoV‐2‐positive (22%). The proportion of SARS‐CoV‐2‐positive patients aged 18–65 years was larger than for other patients in the COVID‐19 unit (84 [72%] v 188 patients [45%]); the proportions of women were similar (53 [45%] v 186 patients [44%]). Median length of stay was longer for SARS‐CoV‐2‐positive than for SARS‐CoV‐2‐negative patients over 65 years of age (182 h; IQR, 87–285 h v 96 h; IQR, 48–158 h), but was similar for all patients aged 18–65 years. Six SARS‐CoV‐2‐positive (18%) and five SARS‐CoV‐2‐negative patients over 65 (2%) were transferred from the COVID‐19 unit to the ICU (Supporting Information, table 3). Seventeen patients hospitalised with COVID‐19 (14%) were admitted to the ICU. The median time from hospital to ICU admission was 2.4 days (IQR, 1.8–3.4 days) for the eight patients over 65, and 5.2 days (IQR, 1.0–6.1 days) for the nine aged 18–65 years; the median ICU stay was 17.3 days (IQR, 3.0–29.3 days) for those over 65, and 2.2 days (IQR, 1.6–4.4 days) for those aged 18–65 years. Four patients died (24%), the only COVID‐19‐related deaths in South Australia (overall case fatality, 0.9%; 18–65 years, 0.3%; over 65 years, 3.2%) (Supporting Information, table 4). Over the past 14 years, 15% of RAH patients with viral pneumonia in intensive care died, with a medium length of stay of 6.2 days (18–65 years, 7.4 days; over 65 years, 4.8 days) (unpublished data). More modest, but persistent, prevalence of COVID‐19 is expected to follow the major pandemic wave of 2020. Our data, gathered in an environment of low community transmission and a health care system with considerably greater capacity than demand, reflects the COVID‐19‐related resource burden that might be anticipated as we prepare for living with COVID‐19. Box 1 – New confirmed cases of COVID‐19 in South Australia, numbers of inpatients with COVID‐19 in the Royal Adelaide Hospital, and numbers of people presenting with potential COVID‐19 infection to the Royal Adelaide Hospital emergency department, 30 January – 26 April 2020 COVID‐19 = coronavirus disease 2019. Box 2 – Care requirements of people with confirmed COVID‐19 admitted to the Royal Adelaide Hospital, 30 January – 26 April 2020 COVID‐19 = coronavirus disease 2019; SARS‐CoV‐2 = severe acute respiratory syndrome coronavirus 2. * Includes one patient initially admitted under a non‐COVID‐19 inpatient team. † Fourteen SARS‐CoV‐2‐positive patients admitted under the COVID‐19 inpatient team required transfer to the intensive care unit, 11 of whom returned to the COVID‐19 inpatient team, as did two of three patients admitted to the intensive care unit from the emergency department. These patients are counted in both intensive care unit and COVID‐19 inpatient team numbers. ‡ includes three intensive care unit patients admitted directly from the emergency department then transferred to the inpatient team, and one patient who was still an inpatient at the end of the study.

Daniel Haustead · Dylan J Toh · Benjamin Reddi · Emily Kirkpatrick · Emily Rowe · Pamela Outhwaite · Elizabett Harnack · Michael Cusack · Megan Brooks

The predominantly age-based structure of the British vaccination program has enabled a rapid delivery with high vaccine uptake

Anthony Harnden · Andrew Earnshaw

Objectives: To estimate initial levels of symptoms of depression and anxiety, and their changes during the early months of the COVID‐19 pandemic in Australia; to identify trajectories of symptoms of depression and anxiety; to identify factors associated with these trajectories. Design, setting, participants: Longitudinal cohort study; seven fortnightly online surveys of a representative sample of 1296 Australian adults from the beginning of COVID‐19‐related restrictions in late March 2020 to mid‐June 2020. Main outcome measures: Symptoms of depression and anxiety, measured with the Patient Health Questionnaire (PHQ‐9) depression and Generalised Anxiety Disorder (GAD‐7) scales; trajectories of symptom change. Results: Younger age, being female, greater COVID‐19‐related work and social impairment, COVID‐19‐related financial distress, having a neurological or mental illness diagnosis, and recent adversity were each significantly associated with higher baseline depression and anxiety scores. Growth mixture models identified three latent trajectories for depression symptoms (low throughout the study, 81% of participants; moderate throughout the study, 10%; initially severe then declining, 9%) and four for anxiety symptoms (low throughout the study, 77%; initially moderate then increasing, 10%; initially moderate then declining, 5%; initially mild then increasing before again declining, 8%). Factors statistically associated with not having a low symptom trajectory included mental disorder diagnoses, COVID‐19‐related financial distress and social and work impairment, and bushfire exposure. Conclusion: Our longitudinal data enabled identification of distinct symptom trajectories during the first three months of the COVID‐19 pandemic in Australia. Early intervention to ensure that vulnerable people are clinically and socially supported during a pandemic should be a priority.

Philip J Batterham · Alison L Calear · Sonia M McCallum · Alyssa R Morse · Michelle Banfield · Louise M Farrer · Amelia Gulliver · Nicolas Cherbuin · Rachael M Rodney Harris · Yiyun Shou · Amy Dawel

During the coronavirus disease 2019 (COVID‐19) epidemic, the continued presence of viral RNA in the upper airways of infected people has been reported.1 Such persistence does not necessarily signify active infection or that the virus can be transmitted.2 In Queensland, repeat testing for severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) in people with an initial positive test result was undertaken until June 2020, providing an opportunity to explore patterns of test positivity, apparent rates of clearance of viral RNA, and the extent to which each varied by the age and sex of the infected person. We analysed de‐identified data for people who underwent swab tests for SARS‐CoV‐2 processed in Queensland Health public laboratories between 10 January and 4 June 2020. SARS‐CoV‐2 RNA was detected by polymerase chain reaction (PCR). Testing was initially restricted to people with relevant symptoms who had visited high risk areas (Box 1); from April 2020, anyone with relevant symptoms could be tested. We analysed data on PCR test result, age and sex of the tested person, and postcode of the facility that requested the test; clinical information and reasons for testing were not available. People with positive results who subsequently received two consecutive negative test results at least 24 hours apart were defined as achieving “negative status”. Details of dataset structure, analysis and visualisation methods and code have been reported elsewhere.3,4 Our investigation was exempted from formal ethics review by the Gold Coast Health Human Research Ethics Committee (reference, LNR/2020/QGC/63045). We analysed data for 103 984 swabs from 97 476 people during the 146‐day study period. Time to negative status was examined by Kaplan–Meier analysis. Differences by age (under 65 years, 65 years or over) and sex, with adjustment for both, were calculated by Cox regression. Other associations between variables were quantified as unadjusted odds ratios. The timing of sample collection, particularly of repeat swabs, was not standardised, reflecting the exploratory nature of SARS‐CoV‐2 testing early in the pandemic. The median age of tested people was 41 years (interquartile range [IQR], 27–57 years; range, under one to 105 years); 55 708 (57%) were female. Nine hundred and fifty‐eight people (0.98%) were positive for SARS‐CoV‐2; their median age was 45 years (IQR, 29–61 years; range, under one to 88 years), and 496 were female (52%). Compared with people under 16 years of age, the odds of a positive result were higher for people aged 17–64 years (odds ratio [OR], 5.2; 95% confidence interval [CI], 3.4–8.1) and for those aged 65 years or more (OR, 6.0; 95% CI, 4.0–9.5); the odds of a positive test were lower for females than for males (OR, 0.80; 95% CI, 0.70–0.91). The numbers of people tested and of those positive for SARS‐CoV‐2 both peaked in the second half of March 2020, after which testing rates declined until late April before climbing again, while positivity rates remained low (Box 1). Of the 958 people with positive test results, 317 (33.1%) had repeat tests. Of the 243 people with initial positive results and at least two repeat tests, 147 (60.5%) achieved negative status. The median age of those who achieved negative status was 45 years (IQR, 30–59 years; range 20–84 years); 94 were women, 53 men (OR, 1.7; 95% CI, 1.0–2.9). Of the 243 people who underwent two or more repeat tests, 224 (92.2%) had positive results beyond 10 days and up to 72 days after their initial tests (Box 2). Seven of 147 people who achieved negative status (5%) subsequently had positive test results, including six men. For the 147 positive patients who achieved negative status, median time to clearance was 31 days (IQR, 18–47 days), and was unaffected by sex (women, 30 days; IQR 16–45 days; men: 31 days; IQR 20–49 days; hazard ratio [HR], 0.93; 95% CI, 0.66–1.3). Clearance was more rapid in people under 65 years of age (median, 29 days; IQR, 17–45 days) than in people aged 65 years or more (median, 43 days; IQR, 25–62 days; HR, 1.82; 95% CI, 1.17–2.93) (Box 3). We found that positive PCR test results often persisted for ten or more days after an initial positive result, in one case for 72 days. Such persistence does not indicate continued viral replication.2,5 From 21 March 2020, patients in Queensland, other than workers at high risk, were released from isolation on the basis of their symptoms and illness duration (ie, without further testing), and local transmission declined to zero (Box 1). Our finding of lower infection rates in younger people is consistent with previous reports,6 as is our finding that infection rates were higher for males than females.7 After adjusting for age, the viral clearance rate was similar for males and females. Clearance was greater for people under 65 years of age than for those aged 65 or more, as noted previously.8 This effect may have clinical significance; rates of hospitalisation, admission to intensive care, and death from COVID‐19 are higher among older people. Box 1 – Numbers of SARS‐CoV‐2 tests processed by Queensland Health public laboratories and of people with positive results, 10 January – 4 June 2020, with trend lines and indications for testing* * Repeat tests after first positive result are not included. Test trend line based on a generalised additive model for “all tests”; positive result trend line based on local polynomial regression fitting. Box 2 – Categorical heat map of SARS‐CoV‐2 tests for people with initial positive results who had at least two subsequent tests Box 3 – Kaplan–Meier analyses of virus clearance in 958 people who were initially positive for SARS‐CoV‐2, by age and sex* * Confidence bands generated by Cox proportional hazards regression, with Efron approximation (coxph function in R 3.6.3).

Paulina Stehlik · Kylie Alcorn · Anna Jones · Sanmarie Schlebusch · Andre Wattiaux · David A Henry

Coronavirus disease 2019 (COVID‐19) and subsequent containment measures affected consumer behaviour in Australia, including the stockpiling of essential items. Increased demand for prescription medications caused concern about potential medication shortages, and a range of policies were implemented in March 2020 to protect supplies.1 We used interrupted time series modelling to quantify the impact of the COVID‐19 pandemic on medication dispensing. The Pharmaceutical Benefits Scheme (PBS) subsidises public medication costs in Australia. We analysed Section 85 date of supply data2 to model dispensing during January 2016 – December 2019, by month, separately for all PBS prescriptions, the ten medications most frequently dispensed during the 2018–19 financial year, hydroxychloroquine, and dexamethasone. These models, which accounted for long term trends and seasonal changes, were used to predict expected dispensing during January – June 2020 (with 95% confidence intervals [CIs]), which we compared with actual dispensing rates during this period (online Supporting Information). Ethics approval was not required for our analysis of publicly available data. The number of prescriptions dispensed during March 2020 was significantly higher than predicted (4.80 million more prescriptions, +18.5%; 95% CI, +14.0% to +23.3%), but significantly lower in April (2.28 million fewer prescriptions, –9.2%; 95% CI, –5.3% to –12.8%) and May (2.08 million fewer prescriptions; –8.1%; 95% CI, –4.3% to –11.5%); there was no significant difference in June 2020 (988 778 fewer prescriptions, –3.8%; 95% CI, –7.5% to +0.1%) (Box). A similar pattern applied to the ten most dispensed medications; the increase in the number of hydroxychloroquine prescriptions dispensed in March was particularly large (24 286 more prescriptions, +95.5%; 95% CI, +89.1 to +102%) (Supporting Information). Increased dispensing of prescription medications in March 2020 was consistent with the general panic buying reported early in the COVID‐19 pandemic.3 Pharmacies also received increased requests for prescription and over‐the‐counter medications at this time, in some cases causing local shortfalls1 and concern that continued high dispensing might interrupt medication supply at the national level. This applied in particular to drugs considered early in the pandemic as potential treatments for COVID‐19, such as hydroxychloroquine. In response to increased dispensing in March, the Australian government rapidly implemented a range of policies for protecting medication supplies. Dispensing limits of one month’s supply were applied to medications if shortages would have serious health consequences.1 These policies reduced the total number of medications dispensed in April and May 2020, followed by the return to normal levels of prescription dispensing in June. Other factors likely to have been important were stockpiles amassed by people during March, public adjustment to the pandemic, and the early suppression of COVID‐19 in Australia. Restrictions on prescription dispensing were balanced by services to assist susceptible patients to isolate themselves; for example, the COVID‐19 home medicines service funded home delivery of prescription medications by community pharmacies and Australia Post,4 and funding for telehealth was increased to facilitate remote prescribing.5 Our findings indicate that medication supply can be safeguarded from panic dispensing by a range of regulatory policies combined with medication services for vulnerable people. This may be particularly important for ensuring equitable access to medications for treating COVID‐19. The risk of further COVID‐19 outbreaks underscores the importance of maintaining these policies and services. Box – Total number of prescriptions dispensed in Australia, January 2016 – June 2020, and numbers of COVID‐19 diagnoses in Australia, January 2020 – June 2020 CI = confidence interval. * Source: Australian Department of Health.2

Mustafa Mian · Subhashaan Sreedharan · Sarah Giles

To the Editor: Modelling commissioned by the federal government estimates that the fertility rate in Australia will drop to an all‐time low of 1.59 babies per woman in 2020–21.1 However, anecdotal observation suggests this projection does not reflect the apparent increase in current bookings for antenatal appointments in our (public) practice. Therefore, we reviewed the use of the five Medicare Benefits Schedule (MBS) item numbers for “microbiological serology during a pregnancy” (ie, 69405, 69408, 69411, 69413 and 69415), as one of these numbers is usually billed at the first antenatal visit. In June 2020, the use of these item numbers increased by 25.4% and later declined to a 9.6% increase in September 2020 compared with September 2019 (Box).2 In the period from 2018 up to the start of the coronavirus disease 2019 (COVID‐19) pandemic, the mean fluctuation in billing volume in the same months over different years was about 3% less or more.2 Therefore, the larger than expected surge in antenatal serology orders since the start of the COVID‐19 pandemic likely represents a significant change in behaviour. Furthermore, this increase in serology testing is on the background of an approximate 3% decline in services for pathology tests not related to COVID‐19 from June to September 2020 compared with the same period in 2019.2 Using MBS item numbers as a surrogate for pregnancy‐related appointment bookings has limitations. In general, women accessing public hospital care may have serology tests done as part of state government funding schemes whereby no MBS item is generated. We cannot exclude the possibility that, in the context of changes related to the COVID‐19 pandemic and a move to telehealth, a higher proportion of women may have had pathology tests done via Medicare. However, it would be expected that if fertility were declining, there would have been a reduction in testing. Furthermore, we were unable to exclude repeat testing, although our experience indicates this would account for an insignificant number of tests. This historical trend, and its context in the timing of an apparent “baby boom” (ie, antenatal serology testing is usually done at around 6–10 weeks’ pregnancy), correlates with an increase in conception starting in late March to early April 2020, during the so‐called first wave of COVID‐19 in Australia. Requests for antenatal serology testing increased by 12 869 from June to September 2020 compared with the same period in 2019 (Box). Factoring in miscarriages, this may mean there will be an additional 11 000 Australian babies born in the third quarter of the financial year 2020–21 compared with the same period in the previous financial year. We believe it is unlikely that fertility rates will drop in 2020–21. Box – Combined Medicare Benefits Schedule (MBS) services for item numbers 69405, 69408, 69411, 69413 and 69415 Month Number of MBS services Variation 2019 2020 June 21 883 27 441 +25.4% July 23 867 26 935 +12.9% August 25 118 27 055 +7.7% September 23 929 26 235 +9.6% Total 94 797 107 666 +13.6%

Len Moaven · James Brown

To the Editor: The coronavirus disease 2019 (COVID‐19) pandemic has created an unprecedented need for real‐time surveillance data to inform decisions and action by public health responders and primary health care practitioners. Early in the pandemic, many countries swiftly produced interactive national dashboards with mapping capabilities.1,2 A dashboard is an online tool for data management which optimises information access and data visualisation.3 Dashboards provide benefits compared with standard reporting, including sharing near real‐time data during rapidly evolving situations, and providing users with the opportunity to interact with the data. If designed appropriately, users can also interrogate data and ask questions based on their specific informational needs. Many dashboards also provide mapping capabilities, allowing for visualisation of spatial distribution of information, and monitoring trends geographically over time.2 Australia does not yet have an official and publicly accessible national interactive dashboard for COVID‐19. Some states and territories have developed publicly available COVID‐19 dashboards, but data are generally aggregated, making it difficult to answer specific questions that include time and location and source of infection. An interactive near real‐time dashboard could improve access to and comprehension of data for primary health care providers and public health responders. Researchers from the Australian National University, Menzies School of Health Research and the University of Queensland are developing a COVID‐19 Real‐time Information System for Preparedness and Epidemic Response (CRISPER) (https://crisper-graphc.hub.arcgis.com/) as a nationwide information and visualisation system for Australia. CRISPER aims to become the principal source of accurate, reliable and spatially explicit real‐time information for COVID‐19 (Box). The system currently uses publicly available postcode‐level data, primarily from state and territory health department websites. Gaining access to nationwide line‐listed data is underway, which will allow additional functionality, including a clinical dashboard detailing clinical outcomes (eg, hospital and intensive care unit admissions, deaths) stratified by demographics, comorbidities, time and place. Also under development is an automatic alert system providing registered users with daily or weekly email alerts on new cases, contract tracing alerts and/or testing rates based on user‐defined geographical areas of interest. We believe that CRISPER will improve accessibility of information for primary health care practitioners and public health responders and will enable them to make more timely and informed decisions. This system may serve as a prototype platform for rapid information sharing for other epidemic‐prone diseases. Box – Features of the Coronavirus Disease 2019 (COVID‐19) Real‐time Information System for Preparedness and Epidemic Response (CRISPER) CRISPER aims to optimise information access and visualisation for COVID‐19 through: a national summaries dashboard detailing cases, deaths and testing — information can be filtered or summarised by states and territories, time periods, and 7‐ or 14‐day rolling averages (https://graphc.maps.arcgis.com/apps/opsdashboard/index.html#/465d9e0cd44247b488b8431a56691417); and an interactive mapping tool of cases, testing and contact tracing alerts by location (postcode, local government areas, public health units) — information can be filtered by time periods and source of infection (currently available for New South Wales). A key feature distinguishing this tool from other dashboards is that the data in the different components are linked; for example, the epidemic curve is dynamic based on cases in the map window (https://graphc.maps.arcgis.com/apps/opsdashboard/index.html#/74e69c2ab40f41c892a652e95373622c)

Emma Field · Amalie Dyda · Colleen L Lau

To the Editor: We thank the MJA for highlighting the fit testing of N95 or P2 respirators in Australian health care workers. Regli and colleagues1 make a compelling case that mandatory fit testing should be implemented in Australian hospitals for frontline staff, in line with South Australian guidelines.2 We note that NSW Health has recently implemented mandatory fit testing in high risk areas.3 We commend these efforts, but they may have important implications that would need planning and consideration in implementation. First, it is clear that anatomical variation of the nasal and malar regions means that some health care workers will only pass the fit tests with particular N95 or P2 respirators.4 This means that along with the implementation of a fit testing program, inventory management systems are also required to facilitate hospital tracking of stocks of particular respirator types and to ensure that sufficient stock is available in high risk areas for individual health care workers. At the Southern Adelaide Local Health Network, we have implemented such a system, which tracks stock levels of all available respirators within the hospital so that key workers who can use only specific types of N95 or P2 respirators will have access to the right type of mask when needed. Second, the coronavirus disease 2019 (COVID‐19) pandemic has disrupted global supply chains, affecting the availability of N95 and P2 respirators. Moreover, fit testing is not a one‐off process, but must be conducted as a rolling program to ensure that all workers have access to appropriately fitting N95 or P2 respirators. Finally, even with an efficient fit testing program, due to anatomical variations, there will always be a proportion of health care workers for whom no masks will be suitable. Along with fit testing, health departments should prioritise health care worker redeployment policies and the development of new technologies to address the needs of the proportion of the workforce with ongoing fit test failure.

Anand Ganesan · Jane Parker · Darius Chapman

Junior doctors face uncertain career progression and futures as a consequence of the pandemic

Kate Johnston · Chloe Tyson · Indra Danny · Lois Meyer

In a new MS diagnosis, immunisation status may be overlooked — careful planning from early in the treatment course is key Multiple sclerosis (MS) is an autoimmune disorder treated with immunomodulatory or immunosuppressive disease‐modifying therapies (DMTs). Immunosuppression predisposes to infection risk, including opportunistic infections; a higher long term risk of some infection‐related malignancies is also likely. Infections in patients with MS may result in increased relapses, functional decline and pregnancy complications.1 Immunisations play a critical role in preventing viral and bacterial infections, and in the setting of DMTs, they require careful and individualised planning from early in the treatment course. Here we provide an Australian perspective on vaccine safety and efficacy when given with DMTs. General vaccination considerations in patients with MS The immunisation status of patients should be considered at the time of MS diagnosis. Standard investigations before DMT initiation are highlighted in Box 1. A full course of vaccinations should be considered for non‐immune patients before commencing a DMT; this is sometimes forgotten in the urgency of managing a new MS diagnosis. Inactivated (non‐live) vaccines contain a killed/inactivated or subunit/conjugate of the pathogen and can be safely administered with DMTs. The immunogenicity of these vaccines when used with DMTs has not been conclusively established. Live vaccinations use an attenuated viral or bacterial strain and are contraindicated with most DMTs because of the risk of disseminated infection when used in immunocompromised states.3 Administration of live vaccines is recommended before DMT commencement (Box 2). Routine vaccinations are not associated with increased MS relapse risk,10 although the risk of relapse associated with yellow fever vaccination remains unclear.11 Immunisations administered in accordance with local guidelines are considered the best strategy for minimising the risk of infections that could trigger MS relapses.9,12 In patients experiencing clinically significant relapses, delaying vaccine administration has been suggested until patients have stabilised and show signs of improvement (typically 4–6 weeks).12 Additional consideration is required for women with MS who are planning a pregnancy. Women should receive live vaccinations before conception to prevent adverse pregnancy outcomes;13 however, DMT cessation to allow vaccination before conception is often not feasible. Vaccination should therefore be explored as early as possible, preferably before commencement of DMT, as it may represent a one‐off opportunity. It is generally considered safe to vaccinate close immunocompetent contacts (eg, family members) of patients on DMTs without risk of disseminated infection.14 Due to the potential for disseminated infection, we recommend delaying recommencement of a DMT by at least 4–6 weeks following the final dose of a live vaccine. Should a patient on a DMT require live vaccines, treatment cessation should be followed by an appropriate washout period before immunisation. No evidence‐based guidelines exist for washout periods between DMTs.15 Patients receiving DMTs with long lasting biological effects (eg, ocrelizumab, alemtuzumab, cladribine) may require prolonged treatment interruption and monitoring to ensure a return to immunocompetency before vaccination (Box 3). The risk of delayed DMT recommencement, including risk of relapse and worsening neurological disability, should be carefully considered against the benefits of immunisation. Ultimately, the long term benefits of vaccination may outweigh the short term risk of relapses. Confirming seroconversion after vaccination is sometimes advised to ensure those who do not generate adequate titres are informed about any possible risk associated with future exposure. An attenuated humoral response is seen with ocrelizumab therapy.27 However, it should be noted that serological testing is insensitive to the contribution of vaccine‐associated cellular immunity, which is likely to offer at least partial protection.29 Individual vaccinations and specific considerations Influenza (non‐live) The seasonal influenza vaccine is considered safe for patients with MS regardless of DMT exposure and is recommended annually.4 Efficacy may be reduced by some DMTs, and seroconversion is attenuated by anti‐CD20 therapy.27 Primary varicella (live) The risks associated with varicella zoster virus infection in patients with MS receiving DMTs highlight the importance of vaccination in this population.30 Vaccination should be considered before DMT commencement in patients lacking demonstrable serological immunity who have an absent or unclear history of chickenpox, shingles or vaccination.31 Varicella zoster reactivation (live) Zostavax (Merck) reduces the risk of shingles and post herpetic neuralgia; it is a larger dose of the live attenuated primary varicella vaccine and is therefore also contraindicated with DMTs.5 Vaccination should be considered 4–6 weeks before commencing any DMT; however, reimbursement in many countries is reserved for older age groups, in whom efficacy may be uncertain.7 Measles–mumps–rubella (live) The combined measles–mumps–rubella vaccine is part of childhood vaccination schemes in most high income countries. It should be administered to patients who lack immunity to any of these viruses before commencing DMT.5 Women planning future pregnancy are advised to have immunity against rubella to prevent adverse outcomes such as miscarriage and congenital defects.5 Pneumococcus (non‐live) Australian guidelines for pneumococcal vaccination are currently in flux; readers are encouraged to check the Australian immunisation handbook for up‐to‐date recommendations.5 Two non‐live vaccines against Streptococcus pneumoniae are available in Australia: a 13‐valent conjugate and a 23‐valent polysaccharide vaccine. The benefits of pneumococcal immunity are potentially significant in the MS population, and the multidose schedule should be particularly applied to patients receiving B cell‐depleting agents, or after immune‐ablative therapies.5 Hepatitis B virus (non‐live) Patients receiving DMTs enter a higher risk category for hepatitis B given their chronic condition, immunocompromise and potentially frequent health care contact.5 Other risk factors to consider include frequent close contact with blood, compromised immunity, intercourse or residence with someone infected with hepatitis B virus, having more than one sexual partner, and frequent travel. To optimise the immune response, the first of three doses should be given before DMT exposure where possible. To prevent treatment delays the remaining doses may be given after DMT commencement. Specialist referral before DMT commencement is required for patients with serological evidence of prior (core antibody positive and surface antigen negative) or chronic (surface antigen positive and/or DNA positive) hepatitis B virus infection, for surveillance and antiviral therapy to mitigate reactivation risk. This is a particular risk with fingolimod and lymphocyte‐ablative therapies. Diphtheria–tetanus–pertussis (non‐live) Vaccination against the highly infectious Bordetella pertussis is routine in Australian children, with a booster recommended for special risk adults including those in close contact with health care, children and infants.5 Vaccination with the diphtheria–tetanus–pertussis vaccine should be strongly considered for patients with MS who lack immunity or have not have a booster within the previous 5 years. Meningococcal disease (non‐live) Combination quadrivalent conjugate meningococcal vaccination is routine for Australian infants, children and adolescents.5 Given their chronic medical condition and immunosuppression, patients with MS treated with DMTs are recommended to receive both combination quadrivalent conjugate and non‐routine meningococcal B vaccinations.5 Further risk factors include frequent travel, individuals living in close quarters, and smoking. Yellow fever (live) Patients with MS planning travel to yellow fever endemic regions should be encouraged to think carefully about their itinerary. A small study of patients not on highly effective DMTs observed a significant increase in relapse rate following exposure to the yellow fever vaccine,11 although this was not corroborated in a recent case series.32 When yellow fever vaccination is essential, DMT cessation with a washout period is required. Given a single‐dose vaccine is protective for life, yellow fever vaccination could be offered before DMT commencement, especially if DMT initiation is delayed for other vaccinations. Concerns regarding the elevated risk of vaccine‐related adverse events in older patients should also be considered.33 When the risk of vaccination outweighs the benefits and the itinerary cannot be changed, a letter detailing why the vaccine cannot be administered should be provided. Patients should also be informed of the quarantine requirements and national policies of their destination. Human papillomavirus (non‐live) Substantial evidence suggests immunocompromise predisposes to persistent human papillomavirus (HPV) infection and related diseases, including cervical and anal cancer.34 HPV vaccination is not routinely recommended for adults, except for immunocompromised patients, and men who have sex with men.35,36 Although data on women with MS are lacking, the nonavalent HPV vaccine should be considered in non‐vaccinated adults and adolescents preparing for, or already taking, DMTs. The use of cervical HPV DNA testing to determine potential benefit from vaccination is not recommended.35,36 The Australian National Cervical Screening Program recommends immunocompromised women with a negative HPV result be re‐screened every 3 years (rather than every 5 years in immunocompetent women).35,36 Travel vaccines Patients with MS should be counselled regarding their itinerary, need to travel, and risks of infections in the context of their travel plans and prescribed DMT. As with other vaccines, non‐live vaccinations are considered safe, whereas live vaccines are contraindicated in those receiving DMTs and must be given after an appropriate washout period. Patients should be made aware that the immunogenicity of non‐live vaccines in the context of DMTs is inadequately studied. Referral to a specialised travel medicine clinic is recommended. Summary Determining immunisation status when commencing DMTs is key, as is an individualised approach to risk–benefit assessment when considering vaccinations. Live vaccinations are contraindicated in patients once they have commenced a DMT. Although we consider it safe to combine non‐live vaccinations with DMTs, data are limited regarding their efficacy and durability. Box 1 – Standard safety and immune status workup before commencing disease‐modifying therapy Varicella zoster serology (IgG) Measles serology (IgG) Mumps serology (IgG) Rubella serology (IgG) Hepatitis B (surface antibody and antigen, and core antibody) and C serology Human immunodeficiency virus serology Syphilis serology Mycobacterium tuberculosis interferon‐γ release assay* and/or chest x‐ray Travel vaccine workup if clinically appropriate Additional considerations: vaccination and infection history; cervical screening * May be affected by immunosuppressive therapies taken at the time of testing; this has been established for patients on teriflunomide and may be the case for other drugs.2 Box 2 – Summary of vaccines Vaccine type Recommendations and comments Influenza* Safe and recommended annually for patients with MS, including those on DMTs4 Varicella zoster virus† primary infection (chickenpox) Give before DMT as two doses at least 1 month apart; consider reducing interval to 2 weeks if DMT commencement is urgent5 Avoid re‐checking varicella zoster virus serology after vaccination, as failure to seroconvert may not preclude functional immunity6 Delaying DMT commencement to retest for seroconversion is also not recommended When DMT cannot be delayed or ceased, antiviral prophylaxis could be considered in high risk circumstances until a window for vaccination arises Prophylaxis could be similarly considered if a patient is inadvertently given live vaccine while receiving DMT5 Varicella zoster virus† reactivation (shingles) Give before DMT Prophylaxis could be considered if a patient is inadvertently given live vaccine while receiving DMT5 Non‐live vaccine may prove useful to patients taking DMTs in future but is currently in global short supply7 Measles–mumps–rubella† Give before DMT in vaccine‐ and infection‐naïve patients — recommended as two doses, at least 1 month apart5 Recommended for women considering future pregnancy, if no evidence of immunity before DMT commencement Patients who lose serological immunity despite exposure or single‐dose vaccination may benefit from single‐dose revaccination8 Patients unable to receive vaccine require education about post‐exposure management Pneumococcus* Adults should be offered a single dose with a follow‐up dose after 5 years The multidose schedule should be particularly applied to patients receiving B cell‐depleting agents, or after immune‐ablative therapies. In adults without a history of pneumococcal vaccination, the preferred order is one dose of 13vPCV followed by a dose of 23vPPV 8 weeks later; if 23vPPV is administered first, then 13vPCV should be administered 1 year later5 Hepatitis B virus* Recommended for patients with MS, who generally fit at‐risk category owing to their chronic condition and immune status Three‐dose schedule at months 0, 1 and 6; where possible, first dose should be given before commencement of any DMT Some flexibility between dosing is permissible: minimal interval between doses 1 and 2 is 1 month; minimum of 2 months between doses 2 and 3; and 4 months between doses 1 and 35 Serological response should be measured and specialist advice sought for vaccine non‐responders Specialist referral before DMT commencement is required for patients with serological evidence of prior or chronic infection Diphtheria–tetanus–pertussis* Vaccination recommended for patients with MS lacking immunity; consider booster before DMT commencement Adults who sustain deep and/or dirty wounds and have not received the vaccine within the previous 5 years should be revaccinated with either diphtheria–tetanus–pertussis or diphtheria–tetanus vaccine5 Vaccination should not be delayed even in patients experiencing an active relapse, as the benefits are thought to outweigh the risks9 In addition, tetanus immunoglobulin is recommended for patients with defective humoral immunity (eg, anti‐CD20 therapy) who sustain such wounds Meningococcus* Patients with MS treated with DMTs are recommended to have both routine combination quadrivalent conjugate and non‐routine meningococcal B vaccinations Also recommended if close contact with laboratories, health care and young children has occurred Close contacts of meningococcal cases should also be considered for post‐exposure prophylaxis with vaccination5 Human papillomavirus* In Australia, vaccination at 12–13 years of age is routine for both females and males; those aged ≤ 19 years are eligible for a government‐funded vaccine, while older patients may need to self‐fund Three doses spaced at 0, 2, and 6 months for people > 15 years (two‐dose schedule for non‐immunocompromised aged under 14 years) Vaccination should be considered in DMT‐exposed, non‐vaccinated adults and adolescents Additional considerations for special groups Travel vaccines: yellow fever†, hepatitis A virus*, typhoid (oral† and intramuscular* vaccines), Japanese encephalitis†, rabies*, cholera†, polio (oral† and intramuscular* vaccines), tuberculosis (bacille Calmette–Guérin vaccine)†, dengue* (not yet available) Q fever* vaccine for people working in abattoirs 13vPCV = 13‐valent pneumococcal conjugate vaccine; 23vPPV = 23‐valent pneumococcal polysaccharide vaccine; DMT = disease‐modifying therapy; MS = multiple sclerosis. * Non‐live vaccine: safe with DMTs but immunogenicity not conclusively established. † Live vaccine: contraindicated with DMTs. Box 3 – Vaccine safety and efficacy with disease‐modifying therapies Disease‐modifying therapy Recommendations Vaccine use in clinical trials Corticosteroids Generally used to accelerate recovery in the setting of a relapse (eg, 3–5 days). Guidelines suggest avoiding vaccinations during clinical multiple sclerosis relapses.9,12 Low dose corticosteroids (< 20 mg/day): safe to give vaccinations.5 Higher dose steroids > 20 mg/day used for < 14 days: give live vaccines 1 month before or any time after treatment;5 some experts recommend waiting 2 weeks after higher dose steroids before giving live vaccines.16 Higher dose steroids used for > 14 days: wait 1 month before live vaccine use. Non‐live vaccines are safe. Teriflunomide Clinical trials and post marketing data suggest non‐live vaccinations are safe and effective during treatment.17 Live vaccines should be avoided during therapy and be given after a washout period of at least 6 months due to prolonged effects on the immune system. Although accelerated washout can be achieved using cholestyramine or activated charcoal, there are no data regarding earlier use of live vaccinations following this. Seasonal influenza vaccine was found to be safe and efficacious.18 A double‐blind placebo‐controlled study evaluated immune responses to a neoantigen (rabies) and recall antigens in healthy subjects treated with teriflunomide. The treatment group achieved seroprotective levels against rabies, albeit at reduced levels compared with the placebo group. Recall antigens were not affected, suggesting no adverse effect on cellular memory response.17Teriflunomide impairs tuberculosis interferon‐γ release assay, which should be cautiously interpreted in this setting.2 Dimethyl fumarate Clinical trials and post marketing data suggest non‐live vaccinations are safe and effective during treatment.19 Use of live vaccinations is not recommended during treatment. If required, the final live vaccine dose should be given 4–6 weeks before the commencement or recommencement of treatment. An open label multicentre study evaluated immune response to tetanus, diphtheria, polyvalent pneumococcal vaccine, and meningococcal conjugate vaccines in patients receiving dimethyl fumarate or interferon. Serological evidence consistent with protection for all vaccines was comparable between the two groups, with no safety concerns raised.19 Fingolimod Clinical trials and post marketing surveillance data suggest that non‐live vaccinations are safe with fingolimod, albeit with impaired efficacy. The use of live vaccinations is not recommended during treatment. A washout period of 2–3 months is recommended to enable immune reconstitution. There are no data to support the use of lymphocyte counts as a marker of immune reconstitution for vaccine safety. The commencement or recommencement of fingolimod should be delayed until 4–6 weeks after the final vaccine dose. Fingolimod has also been associated with infection‐associated malignancies such as cervical cancer. Careful observance of screening programs is recommended. A blinded randomised placebo‐controlled study evaluated vaccination response in 138 fingolimod‐treated patients. The response rates for novel antigen influenza vaccine (fingolimod v placebo) were 54% and 85%, respectively, at 3 weeks, and 43% and 75%, respectively, at 6 weeks after vaccination. For tetanus toxoid, response rates were 40% and 61%, respectively, at 3 weeks, and 38% and 49%, respectively, at 6 weeks after vaccination. The authors concluded that, despite reduced vaccine response, patients remained capable of producing antibody levels consistent with protection.20 Cladribine Use of live vaccinations is not recommended during treatment, and treatment should not be initiated within 4–6 weeks after live vaccinations. The manufacturer recommends against live vaccination during or after a treatment, until white blood cell counts have normalised.21 Data regarding safety or efficacy of vaccines following treatment are lacking. Live vaccines were prohibited in the placebo‐controlled CLARITY trial.22 Several patients were exposed to non‐live vaccinations with no adverse events reported. The optimal timing of vaccination with regard to treatment, and the impact of cladribine therapy on vaccine efficacy, are not known. Natalizumab Clinical trials and post marketing surveillance data suggest that non‐live vaccinations are safe and effective during treatment. The use of live vaccinations is not recommended during therapy. A phase 4, open label, randomised study measured response to tetanus in natalizumab‐treated patients, all of whom achieved protective levels of tetanus antibodies.23 A study found no statistically significant difference in mean influenza IgG levels between patients receiving natalizumab and healthy controls following vaccination, suggesting maintained humoral immune response.24A study observed reduced long term protection after H1N1 influenza vaccination in natalizumab‐treated patients; the authors suggested the need for two vaccine doses in the setting of an influenza pandemic.4 Alemtuzumab Alemtuzumab treatment should be delayed for 6 weeks following the final dose of a live vaccine. The efficacy of non‐live vaccines during or after alemtuzumab therapy for multiple sclerosis is unclear. One study suggests patients are able to maintain viral immunity following treatment. Data regarding the safety of live vaccines following immune reconstitution are also lacking; this may in theory be safe, especially if T and B cell subsets have normalised. A case–control study observed preserved serological response to diphtheria, tetanus, polio, Haemophilus influenzae, meningococcal C and pneumococcus vaccines in alemtuzumab‐treated patients.25 Pre and post alemtuzumab antibody levels to common viruses (measles–mumps–rubella, varicella zoster and Epstein–Barr) were comparable with historical controls, suggesting pre‐existing immunity does not decline after treatment.25 Data from alemtuzumab used for rheumatoid arthritis suggests that vaccine response to both neoantigens and recall antigens returns to normal and remains normal up to 20 years.26 Ocrelizumab, rituximab Vaccine response in patients receiving anti‐CD20 agents may be attenuated.27 It is therefore recommended that all necessary vaccines be completed before anti‐CD20 treatment. Anti‐CD20 therapy should be delayed for 4–6 weeks following the final dose of a live vaccine. The safety of immunisation with live vaccines following ocrelizumab has not been studied and it is therefore not recommended during treatment and until B cell repletion (which may take up to 72 weeks).28 Ocrelizumab exposure during pregnancy may result in neonatal B cell depletion, which may impact the safety and efficacy of neonatal vaccinations. Monitoring of neonatal CD19 counts is recommended, and vaccines should be administered only after normalisation.28 Following treatment for over 2 years, the proportion of patients with positive antibody titres against pneumococcus, measles–mumps–rubella and varicella zoster virus were similar to baseline, suggesting CD20 B cell depletion does not impact pre‐existing protective viral antibodies.28 A randomised controlled trial investigated the impact of ocrelizumab therapy on response to tetanus, influenza and pneumococcus vaccines. An adequate vaccine response was mounted by all patients but was attenuated in the ocrelizumab group relative to the control group.27

Cassie Nesbitt · Louise Rath · Michael Zhong · Allen C Cheng · Helmut Butzkueven · Robb Wesselingh · Olga Skibina · Mastura Monif · Wei Yeh · Julia ML Brotherton · Stephen Reddel · Anneke Van Der Walt

To the Editor: In a recent letter published in the MJA, Muhi and colleagues1 reviewed the source of acquisition by 11 health care workers with coronavirus disease 2019 (COVID‐19) who presented for symptomatic screening at a single clinic. Travel and transmission outside the workplace were considered the likely source of infection for most of them. Data on COVID‐19 cases collected for public health purposes in Western Australia up to 1 June 2020 were reviewed to inform local public health strategies to protect health care workers. Fifty‐seven cases of COVID‐19 among health care workers or workers in health care settings with direct patient contact were identified. Fifty‐six cases were confirmed by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) polymerase chain reaction (PCR) test, and one case had positive SARS‐CoV‐2 IgG serology indicating past infection. Thirty‐one health care workers acquired their infection from a cruise ship or overseas, and 26 health care workers acquired COVID‐19 within Australia. The likely source of the 26 locally acquired cases is shown in the Box. Ten health care workers acquired the infection in the workplace. A further eight had no known contact with a COVID‐19 case but worked during their incubation period. These health care workers may have acquired the infection from an unidentified patient with COVID‐19, from another health care worker, or via fomite transmission at work. Extensive contact tracing did not reveal an alternate source in a setting of limited community transmission. Where possible, whole genome sequencing was used to substantiate epidemiological findings. Transmission of COVID‐19 occurred between health care workers, emphasising the need for staff to recognise not only the risk from patients but also from colleagues, where use of personal protective equipment and physical distancing may be relaxed. There were no cases among staff in COVID‐19 clinics, suggesting that the use of personal protective equipment does mitigate risk. Workplace fomite transmission was the putative source on three occasions, which reinforces the importance of regular environmental cleaning, rigorous cleaning of shared equipment, and good cough etiquette and hand hygiene practices within health care facilities. Our review describes a larger cohort of COVID‐19 cases among health care workers, encompassing metropolitan and regional settings. With international travel restrictions, an increasing proportion of locally acquired infections among health care workers may be expected. From this analysis and others,2 colleagues and fomites should be recognised as potential workplace sources of infection, in addition to direct patient contact. Box – Likely source of coronavirus disease 2019 (COVID‐19) infection for locally acquired cases by Western Australian health care workers (HCWs) Source of infection Cases Direct HCW to HCW transmission 7 Likely fomite transmission 3 Unknown, but worked during incubation period* 8 From a close contact outside of work 5 Contact not identified, but interstate travel 3 Total 26 * No alternate source of infection identified in the context of limited community transmission.

Rebecca J Hogan · Suzanne McEvoy

To the Editor: The clinical trial landscape has arguably progressed more in the past 6 months than in the previous 10 years. The needs of humanity in the global pandemic catalysed the necessity to evaluate study design, implementation, governance, technology and collaboration. The race for effective therapies and a vaccine highlighted the need to expedite drug development and approval. While clinical trials in oncology have used master protocols for many years, with clear guidance from regulatory authorities1 and a gradual adoption in other therapeutic areas,2 these have become the blueprint for coronavirus disease 2019 (COVID‐19) clinical trials developed by the World Health Organization, ensuring the ability to test a broad range of therapies. COVID‐19 has also triggered the adoption of technology to support trials, accelerating the move to a digital age of clinical trials.3 Platforms to deliver online recruitment, electronic consent, wearable devices, artificial intelligence and electronic systems for source data and regulatory documents now provide the solution to maintaining clinical trials activity, at a time when restrictions challenge the viability of face to face trial operations. The need for comprehensive, integrated electronic medical records is evident, with enduring access for parties for data verification, but raises issues of access, privacy and cybersecurity. Out of necessity, clinical trials have also adopted teletrials, like the need in medical practices to adopt telemedicine,4 resulting in a dispersed, decentralised model of operation. The pressure to adapt clinical trial delivery has seen previously perceived barriers fall away. By focusing on common goals, collaboration, technology, and building solid foundations to evaluate our progress to ensure research integrity and safety, a new era of clinical trials will unfold. The clinical trials team of the future will evolve, incorporating a core team with information and communication technology capabilities to support training, management and development of trial systems in a networked model of delivery. While this is a welcome push into a new technological era, with an opportunity to retain new elements and abandon outdated models, we must proceed with thoughtful consideration and evaluation of our progress.

Alana Sarah · Olivia Dean · Michael Berk

To the Editor: Despite death being common in aged care, bereavement support for family and others is not part of care.1 In contrast, palliative care inherently extends to the patient’s family members, including after death.2 Coronavirus disease 2019 (COVID‐19)‐related deaths in aged care have left many families bereft. This is a consequence of forced separation in the final stage of life, the family member being transferred to an acute hospital, the question of whether the patient died alone, and limitations on traditional rituals and practices surrounding funerals.3,4 Like many community palliative care services, Melbourne City Mission’s Palliative Care (MCMPC) services have a well established aged care consultative team that provides advice on complex end‐of‐life issues. At the beginning of the COVID‐19 pandemic, MCMPC started to receive referrals for bereavement support — rapid referrals for residents in aged care facilities in the terminal phase of illness to speak with their families both before and after the patient’s death. Examples of catastrophic grief resulting from the COVID‐19‐related deaths in aged care facilities overseas prompted MCMPC’s preparation to respond to traumatised relatives.5 This work simply involved a phone call to families after the patient’s death. What was heard was sobering, summed up by one family member as “it was not meant to be this way”. Families expressed disappointment that the resident had contracted COVID‐19, stating they should have been safe in their home. The bereaved spoke of their enormous loss, having not been able to be with their loved one, in some cases, for a period of over 7 months. While most families were realistic about the frailty of their family member, they also said that “it was not their time,” that COVID‐19 unfairly changed the trajectory of how they expected their last days or months to go. Palliative care has much in common with aged care, notably the care of patients who are facing the final stage of their life. For staff it has been important to give each bereaved person a chance to capture their individual story, to give identity to the person who died, so they are not just another of the many deaths in aged care. In validating family members’ experiences, this simple phone intervention may mitigate poor bereavement outcomes5 by providing a space to honour their loss.

Margaret O’Connor · Bronwyn Wilson

To the Editor: Public health strategies to control coronavirus disease 2019 (COVID‐19) in Australia aim to test, identify and isolate all cases including those among children.1 We investigated the intended actions of parents if their child developed COVID‐19 symptoms, such as a runny nose, sore throat, cough, fever, chills, loss of smell, diarrhoea, and/or nausea and vomiting.1 We collected data during 15–23 June 2020 via an online survey of 1834 Australian parents of children aged 3–17 years who attended childcare, kindergarten and/or school.2 The sample was limited to these respondents as one of our objectives was to test if children would be kept home from childcare and/or school (isolate). The questionnaire was administered by a private vendor as part of the Royal Children’s Hospital National Child Health Poll, a recurring periodic online survey. Participants were randomly selected from a representative consumer panel of over 350 000 Australian adults — who were recruited onto the panel via online and offline methods such as door knocking, phone calls, letters etc — using quotas to achieve a nationally representative sample reflective of age, sex and state populations. The sample size was justified based on the commonly used margin of error of 3% for estimating a proportion. Only one parent per household could complete the questionnaire and households were not permitted to participate in more than one poll. Participants had no direct contact with the research team. Responses were voluntary and anonymous. Respondents were incentivised for participation in the form of points towards shopping gift cards. The study protocol was approved by the Royal Children’s Hospital Human Research Ethics Committee (RCH HREC 35254). Intended actions of parents if their child developed possible COVID‐19 symptoms are presented in the Box. We classified parents as “seeking COVID‐19 test or medical advice” or not. The sample characteristics are presented in the Supporting Information. We found that 1458 of 1834 parents (78.95%, weighted) of children with symptoms compatible with COVID‐19 intended to seek a COVID‐19 test for their child. There is little published research exploring why some parents may not present children for COVID‐19 testing. A recent Australian study has identified barriers to testing among adults, including a belief that testing is painful, a lack of knowledge about how to get tested, and worry about getting infected at the testing centre.3 These barriers may also apply to parents in relation to testing for children. Additional barriers may include financial implications of time off work to take a child for testing and fear of the social stigma associated with a diagnosis of COVID‐19.4 As upper respiratory tract infections are common among children and often present with similar symptoms to COVID‐19,1 parents may misattribute possible COVID‐19 symptoms to the common cold. Messages from governments may be unclear and parents may not believe that general directives apply to children.5 Timely testing is a critical aspect of containing the pandemic in Australia. With one in five parents indicating they would not present their symptomatic child for COVID‐19 testing, further research is urgently needed to identify and understand barriers to testing in order to inform targeted strategies and messaging to enhance testing uptake in children. Box – Intentions of parents if child developed symptoms compatible with coronavirus disease 2019 (COVID‐19), Australia, 2020 Number (%)*† Keep child home from school or child care until all their symptoms have gone 991 (53.22%) Take child to a doctor (GP or hospital) for a COVID‐19 test 810 (44.66%) Keep child home from school or child care for a couple of days 672 (36.34%) Call the GP for advice 618 (33.62%) Take child to a COVID‐19 testing centre 452 (23.33%) Call the COVID‐19 hotline for advice 415 (22.69%) Send child to school or childcare if they seem well enough 47 (2.66%) Not sure what to do 34 (1.73%) Take child for test‡* 1458 (78.95%) GP = general practitioner. * The cumulative percentage is greater than 100% as respondents could select more than one option. † The sample was nationally representative in terms of the distribution of national resident population by state; however, the distribution of parent sex by state and socio‐economic status was slightly over‐representative of female and more advantaged residents (Supporting Information). Hence, the data were weighted by state, sex and the Index of Relative Socio‐economic Advantage and Disadvantage (IRSAD). ‡ “Take child for test” was defined as at least one of the following options: take child to doctor or testing centre for a test, call GP for advice or call the COVID‐19 testing centre.

Mary‐Anne Measey · Monsurul Hoq · Anthea L Rhodes

The COVID‐19 pandemic has necessitated rapid uptake and use of telehealth, unmasking a number of concerns potentially not previously contemplated by clinicians, patients and legislators In the physical distancing climate of coronavirus disease 2019 (COVID‐19), the ubiquity of virtual communications in medical practice generates a number of challenges. Consultation via telehealth allows for creation of audiovisual documentation of the clinical interaction as well as observation by unseen parties from each participant’s perspective, either in real time or subsequently via review of any recordings. It is necessary for clinicians to i) obtain informed consent for clinician‐led recordings, ii) be aware of potential patient‐generated recordings (both declared and undeclared), and iii) meet legal, privacy and storage requirements pertaining to health information arising from a virtual consultation. Consent to participation Observing next of kin or third parties to a virtual telehealth consultation must be introduced to the treating clinician in a manner consistent with an in‐person consultation, whereby such an individual would, with the patient’s consent, attend the consultation with the patient. In considering the clinician’s screen, consent for clinician participation is implied, but should be specifically broadened where appropriate to allow for the presence of clinical observers. Indeed, the clinician’s duty of confidentiality still applies to telehealth consultations, necessitating awareness of others within earshot or visual proximity to the consultation. Implications of virtual participation The benefits of a virtual consultation include participation and collaboration with members of the patient’s family previously unable to participate, as well as increased access to health care for patients with particular physical challenges or vulnerabilities, including vulnerability to infection with COVID‐19. Interviewing a patient in their home adds rare insights for a clinician not typically engaged in home visits, including opportunities for environmental observation, which may be of clinical value. The home setting allows for involvement of parties (seen and unseen) potentially contrary to the patient’s best interests. Pertinent examples include family violence or elder abuse contexts, where presence of offenders may jeopardise the clinical encounter and may pose direct risks to the patient in the periconsultation period and subsequently via covert audio or video footage. A 2020 article provided insights on screening questions for detecting and navigating potential abuse during telehealth consultations in the setting of a COVID‐19‐related domestic violence epidemic secondary to government‐imposed social restrictions.1 Beyond clinical value, novel forms of documentation (including audiovisual recording) generated within the consultation may benefit research, education, billing and coding, subject to appropriate ethical and consent obligations. The content of a traditional clinical consultation episode is limited to the parties in the room and, to a defined extent, other parties (via review of written documentation). In the telehealth context, a wide audience can potentially review video footage of the consultation, as if they were there, for an indefinite period. This may have implications for the practicalities and duration of storage required of such material, its latent role as discoverable documentary evidence in future litigation (particularly given the persuasive nature of audiovisual documentation), and in substantiation of episodic care funding. Clinical interactions may incorporate questions or discussions that, while appropriate sequentially, may appear inappropriate, deficient, discourteous or misleading if taken out of context or distilled to a single statement or query. Recordings, and their potential edits, could be used by patients in a maladaptive manner, engender abnormal illness behaviour, or make a participant consciously or unconsciously feel the need to perform or otherwise change clinical interactions. Recordings by the patient The likelihood of a patient recording a clinical encounter is much higher in the age of telehealth, when secret recording is increasingly possible. The legality of recording a private conversation without consent depends on the state or territory where the person undertaking the recording resides, as surveillance legislation is largely a matter for these jurisdictions (Box 1). In New South Wales, South Australia, Tasmania, Western Australia and the Australian Capital Territory, it is an offence to record a private conversation. This was upheld in NSW in Toth v Director of Public Prosecutions, where it was held that a patient secretly recording a consultation with a general practitioner was an offence.2 However, in Victoria, Queensland and the Northern Territory, it is lawful to record a private conversation without consent if you are a party to the conversation.3,4,5 In all jurisdictions, it is generally not permissible to publish or communicate information secretly recorded. However, exceptions exist; for example, in Victoria, the prohibition on publication or communication of information secretly recorded does not apply to subsequent use in the course of legal or disciplinary proceedings.6 Courts may be more receptive to the notion of undisclosed recordings for defensive purposes where there is a reasonable belief that a recording might be necessary to address a substantive harm. Thus, in certain jurisdictions, patients can secretly record a consultation without the consent of the clinician and this recording may be used in legal or disciplinary proceedings. These risks are best described as emerging given the widespread use of telehealth and the paucity of reported examples of recording. It should also be stressed that when practitioners are behaving professionally and meeting the appropriate standard of care, the medico‐legal risk of patient recordings is minimal. Practical measures to prevent patients from secretly recording screens include disabling the in‐built recording functions in telehealth platforms, using platforms lacking this recording option, and employing programs preventing screen recording or superimposing watermarks including publication preclusion. However, such measures will not prevent another party from recording a consultation with an additional device. Provision of documented restrictions to the patient at the time of any patient‐generated recording and co‐recording by the clinician (to ensure record integrity) may be of value. However, an automated message before consultation commencement expressly stating the clinician does not consent to screen recording (intending to effect a licence agreement or permit a gag order) is unlikely to achieve this in jurisdictions allowing patients to record without the clinician’s permission. Recordings by the clinician Key to understanding and managing both consent and any recordings is the status of these recordings at law. The definition of health information as defined by the Privacy Act 1988 (Cth) s 6FA is broad, including not only information pertaining to someone’s health but also personal information collected to provide, or in providing, a health service to an individual.7 Interpreted literally, any information pertaining to a patient that is recorded, irrespective of consent, may be considered health information with requirements for storage in compliance with the relevant state or territory health records and/or freedom of information legislation (Box 2). In Australia, under the Privacy Act 1988 (Cth) as well as relevant state and territory legislation, a patient’s medical records will generally be held and owned by the clinician or health care organisation, but patients are entitled to access and take a copy of their records. However, concepts of data sovereignty are changing.8 Patient‐driven and centralised health records (such as collaborative digital hospital files and My Health Record) are contemporary examples of this, with reduced clarity about the roles and responsibilities of potential contributors (including the patient) to a medical record as well as the ownership of that information. Various jurisdictions within Australia legislate minimum periods for medical record‐keeping, generally 7 years from the date of the last record entry for adults and until the age of 25 years for children. Many variations exist, based on state or territory, whether the records reside in a public or private institution, or relate to public health, quality improvement, disability, implants or artificial devices, sexual assault counselling, or child protection. Efficient and safe storage of electronic health information by clinicians, including telehealth recordings, is increasingly challenging. Considerations include provisions regulating onshore versus offshore and cloud‐based storage technicalities, including encryption inherent in the platform of choice, preventing evolving real‐time threats to health information security (including via insurance and strategic risk mitigation), and compliance with legislated security requirements. The omnipresence of personal digital devices, including smartphones, has irrevocably altered the role and prevalence of clinical photography, videography and digital team communication tools, constantly generating much data, not all of which are routinely stored by health services or clinicians relying on them to guide clinical decisions. Clear documentation of consent to recording of digital information by clinicians is important, and that consent should extend to the purpose of the recording. When the patient provides their consent, the use of the recording should be limited to that purpose.9 Recording of telehealth discussions between health care workers, including multidisciplinary meetings and case conferences, engenders further challenges. Recordings may be helpful for updating absent clinicians, minute taking, education or documentation. However, such recordings constitute health information, necessitating compliance with management and storage requirements applicable to a virtual consultation. In the public sector, patients may have access to recordings under freedom of information legislation, potentially resulting in significant alterations to the dynamic and tone of the discussion. This is a complex area of law which varies among jurisdictions but is worth keeping in mind. Where there is uncertainty, proactive discussion with medical indemnity providers may be invaluable, especially given the heterogeneity of legal obligations upon clinicians across jurisdictions. Conclusion In Australia, the COVID‐19 pandemic has necessitated rapid uptake and use of telehealth. This has unmasked a number of concerns potentially not previously contemplated by legislators, patients and clinicians, particularly concerning the recording of clinical consultations and thereby the creation of health information, with extensive associated data management and security compliance challenges. Recording of clinical conversations or processes may enhance patient and clinician participation, self‐reference, research, education and funding. In certain jurisdictions, however, clinical consultations or meetings may be lawfully recorded with or without participants’ knowledge, and may later be accessible to the patient, including for use in future legal or disciplinary proceedings, potentially stifling candid discussion. This and the challenging obligations relating to data management technicalities represent real risks for clinicians and health services. It is incumbent upon health care providers and lawmakers alike to consider these issues in a practical context, ensuring that telehealth is not only a useful tool but a safe and effective one. Box 1 – Legislation governing covert recordings State or territory Legislation pertaining to recording Australian Capital Territory Listening Devices Act 1992 (ACT) New South Wales Surveillance Devices Act 2007 (NSW) Northern Territory Surveillance Devices Act 2007 (NT) Queensland Invasion of Privacy Act 1971 (QLD) South Australia Listening and Surveillance Devices Act 1972 (SA) Tasmania Listening Devices Act 1991 (TAS) Victoria Surveillance Devices Act 1999 (VIC) Western Australia Surveillance Devices Act 1998 (WA) Box 2 – Legislation governing health information management Jurisdiction Legislation governing health information management (not including legislated regulations) Federal Privacy Act 1988 (Cth); Personally Controlled Electronic Health Records (Consequential Amendments) Act 2012 (Cth); My Health Records Act 2012 (Cth); Freedom of Information Act 1982 (Cth) State or territory Australian Capital Territory Health Records (Privacy and Access) Act 1997 (ACT) New South Wales Health Records and Information Privacy Act 2002 (NSW) Northern Territory Health Services Act 2014 (NT); Information Act 2002 (NT) Queensland Information Privacy Act 2009 (QLD); Right to Information Act 2009 (Qld); Public Records Act 2002 (QLD) South Australia Freedom of Information Act 1991 (SA); State Records Act 1997 (SA) Tasmania Personal Information Protection Act 2004 (TAS); Right to Information Act 2009 (TAS) Victoria Health Records Act 2001 (VIC); Privacy and Data Protection Act 2014 (VIC); Freedom of Information Act 1982 (VIC); Public Records Act 1973 (VIC) Western Australia Freedom of Information Act 1992 (WA); State Records Act 2000 (WA)

Caitlin C Farmer · Sam C Pang · Dev Kevat · Jessica Dean · Danielle Panaccio · Patrick D Mahar

Many patients had persistent symptoms two months after diagnosis, including fatigue, chest pain, and breathlessness

David R Darley · Gregory J Dore · Lucette Cysique · Kay A Wilhelm · David Andresen · Katrina Tonga · Emily Stone · Anthony Byrne · Marshall Plit · Jeffrey Masters · Helen Tang · Bruce Brew · Philip Cunningham · Anthony Kelleher · Gail V Matthews

To the Editor: The coronavirus disease 2019 (COVID‐19) pandemic has raised concerns of a subsequent increase in suicides,1 but limited empirical data are available on this topic.2,3 We analysed numbers of suicidal presentations (including suicidal ideation, non‐suicidal self‐injury and suicide attempts) to emergency departments (EDs) within the Gold Coast Hospital and Health Service before and since the spread of COVID‐19 in Queensland, Australia. Cases were identified from ED administrative data through relevant diagnoses, presenting problems and keywords, followed by a manual investigation of triage narratives to exclude false positive cases, such as non‐deliberate injuries or poisonings. The numbers of ED visits between January and August 2020 were compared with the projected numbers, calculated by applying an annual increase of 13.5%4 to presentations during the same period in 2019. From March 2020 onwards, a marked divergence between observed and projected numbers is noted, corresponding to the oscillations in the numbers of diagnosed COVID‐19 cases in Queensland (Box). At the peak of the pandemic, the reductions in suicidal presentations were the largest (29.8% in March and 23.6% in April 2020). Over the next 2 months, daily numbers of diagnosed COVID‐19 cases remained low and the difference between observed and projected numbers gradually narrowed (20.8% in May and 14.6% in June 2020). In July 2020, observed numbers exceeded projected numbers by 11.4%, but then declined again in August 2020, coinciding with another resurgence of COVID‐19. Between March and August 2020, the Gold Coast Hospital and Health Service had 554 less suicidal presentations than expected. The well documented negative impact of COVID‐19 on all aspects of society, including mental health,5 suggests that a substantial reduction of suicide risk during this time is unlikely. Instead, our results may reflect changes in help‐seeking behaviour, with fewer people willing to seek help for suicidality through in‐hospital consultations due to fears of contracting COVID‐19.6 Ongoing promotion of telehealth and enabling safe hospital presentations or alternatives to ED7 is therefore needed to prevent the adverse outcomes of the COVID‐19 pandemic due to delayed access to care. Limitations of this work include potential underestimations of suicidal presentations due to coding issues8 and the inability to differentiate between types of suicidal presentations. Box – Numbers of suicidal presentations to the Gold Coast Hospital and Health Service in 2019 and 2020, and numbers of daily coronavirus disease 2019 (COVID‐19) cases in Queensland, Australia Error ranges for the projected 2020 numbers are 95% confidence intervals.

Jerneja Sveticic · Nicolas JC Stapelberg · Kathryn Turner

To the Editor: Siru and colleagues have raised potential concerns about the strategy recommended by the Australian Diabetes Society (ADS) and other peak bodies to diagnose gestational diabetes (GDM) during the coronavirus disease 2019 (COVID‐19) pandemic.1 In their study, 46% of subjects diagnosed with GDM had a fasting blood glucose level (BGL) < 4.7 mmol/L but elevated post‐load blood glucose levels, and would be missed by the ADS‐recommended strategy. The authors suggested that this exposes women and their newborns to significant risks with the potential for significant harm. No outcome data were provided to justify these assertions. Evidence from the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study suggests that such women do not have increased rates of pregnancy‐associated complications.2,3,4,5 The subgroups with the highest odds ratios for newborns who were large for gestational age had an elevated fasting BGL and any elevation of post‐load BGL (odds ratio > 3), whereas subgroups having only elevated fasting or post‐load BGL had a considerably lower odds ratio, equivalent to the diagnostic threshold for GDM of 1.75.2 Further, women with a fasting BGL < 4.5 mmol/L had low rates of some complications irrespective of their post‐load BGL.3 A subsequent analysis of 6128 patients from five centres involved in the HAPO study did not observe any increase in pregnancy‐associated complications in women with a fasting BGL below the 75th centile (4.6 mmol/L).4 A recent analysis of 5974 women in the HAPO study assessed the ADS‐recommended COVID‐19 GDM strategy and reported no increase in any complication.5 There were fewer cases of pregnancy‐associated hypertension and caesarean delivery, with similar rates of large‐for‐gestational‐age newborns and neonatal hypoglycaemia. These data provide reassurance. There is no evidence of harm. When this strategy is used, women with a fasting BGL < 4.7 mmol/L are spared being labelled with GDM and do not require education, monitoring, more frequent follow‐up or transfer to specialist services, freeing up valuable health care resources. Importantly, they will not be advised to inappropriately restrict their dietary intake or commence therapy with insulin or metformin with the potential for harm. An initial fasting BGL test would eliminate the need for a pregnancy oral glucose tolerance test in the majority of women, identifying a smaller group of women at risk of pregnancy‐associated complications where management can be more appropriately targeted.

Michael C d'Emden · Jacobus PJ Ungerer · Susan J Jersey

CHRIS supported the Victorian ICU response during the COVID‐19 pandemic The coronavirus disease 2019 (COVID‐19) pandemic put an unprecedented strain on intensive care resources throughout the world. Initially in Wuhan (China)1 and then in Lombardy (Italy),2 London (United Kingdom) and New York (United States),3 demand exceeded capacity, with 10–15% of the patients admitted to hospital developing critical illness. Australia has 191 adult and paediatric intensive care units (ICUs), with over 2300 ICU beds.4 This is equivalent to 8.9 ICU beds per 100 000 population, more than the UK but fewer than Italy and the US.5,6 In late March 2020, rising numbers of COVID‐19‐related admissions to ICUs were observed throughout Australia.7 The Australian and New Zealand Intensive Care Society (ANZICS) and the Australian Government Department of Health recognised that ICU demand was unlikely to be uniform, that capacity might be exceeded in one region but not in another, and that matching ICU resources to areas of greatest need might be required. A single sentence encapsulated the approach: “Why would we let a patient die in Western Australia if we can see a spare ventilator in Sydney?” A nationwide system to monitor ICU demand and capacity in Australia A nationwide dashboard of ICU activity, the Critical Health Resources Information System (CHRIS), was rapidly developed as a collaboration between Telstra Purple, Ambulance Victoria, ANZICS and the Australian Government Department of Health. All adult and paediatric ICUs (public and private) in Australia were instructed to enter data twice daily. This manual data entry typically took 5 minutes. Each ICU was immediately able to see patient numbers and resources available within every ICU in their region and also see an aggregate summary of all ICUs in Australia. CHRIS was available to all state and territory health departments, to all patient transport and retrieval agencies, and also to ICUs in New Zealand. The system went live on 1 May 2020, after 26 days of development. Three weeks later, 184 out of 188 eligible ICUs (98%) in Australia were contributing data. The ICU response to the second wave of COVID‐19 in Victoria After a decline in severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) infections throughout Australia, notifications rose again in Melbourne at the end of June 2020.8 In response, ICU directors from the lead hospitals of the nine designated Victorian health care clusters commenced a daily morning meeting with representatives from Ambulance Victoria, Safer Care Victoria and the Victorian Department of Health and Human Services. The group committed to maintaining standards of care expected under normal (non‐pandemic) conditions and to achieving this by proactively transferring patients (with or without COVID‐19) to another ICU if delivery of care was compromised by high local demand. Decisions to transfer patients were informed by data from CHRIS. Pre‐existing critical care transfer systems run by Ambulance Victoria were used. From the beginning of July to the end of September 2020, there were 237 ICU admissions with COVID‐19 pneumonitis, of which 210 (88%) occurred in July and August. Admissions were predominantly to public hospitals in north‐western Melbourne.9 The rapid and localised nature of presentations meant that it was faster to transfer patients to ICUs with vacant capacity than to open and staff additional beds, despite physical ICU bed spaces being available. Transfers from the emergency department or ICU at the four north‐western metropolitan hospitals alone accounted for 35% (46/133) of all critical care transfers in Victoria during July and August. Spare ventilators were available at all sites on all days. On six occasions in August, there were more than 140 ventilated patients (with or without COVID‐19) in Victoria. On each of these days, there were more than 500 spare ICU ventilators available (Box 1 and Supporting Information, graphic 1 in the video). Despite individual hospitals indicating transient increases in ICU bed numbers, there was no overall increase in open staffed ICU beds. As COVID‐19 cases rose, so too did numbers of critical care staff unavailable due to COVID‐19 exposure or illness, with 15 consecutive days when there were more than 60 staff unavailable (Box 2). Lessons learned CHRIS provided real‐time data on ICU activity and capacity. In addition to facilitating the transfer of critically ill patients, CHRIS also enabled early diversion of ambulance presentations to emergency departments at hospitals where ICUs had capacity. These approaches were integral to ensuring standards of care were maintained by clinicians, retrieval agencies and the Victorian health department. At the same time, there was visibility to the Australian Government Department of Health, which would, if required, coordinate a national response to overwhelmed ICU services. Although several individual ICUs came under strain, retrieval and critical care systems in metropolitan Melbourne were not overwhelmed. Strategies to redistribute critical care demand are likely to have contributed to high survival rates for ventilated patients with COVID‐19 in Victoria.9 Timely transfers to ICUs with open available beds could be facilitated. Availability of staff was more important in determining capacity to deliver care than availability of ventilators. The role for CHRIS in the future The local application of a national tool (CHRIS) for real‐time display of ICU activity and resources was a key component of the response to the COVID‐19 pandemic in Victoria. CHRIS has the potential to augment existing ICU monitoring systems. The tool may also assist in the response to local and national public health emergencies, such as mass casualty events, bushfires10 or thunderstorm asthma.11 Automated linkage of CHRIS to existing state‐based and national systems should be investigated. In addition, it may have potential use in monitoring health policy impacts more broadly. Box 1 – Snapshot of the Critical Health Resources Information System (CHRIS) summary page for Victoria during August 2020 ACT = Australian Capital Territory; COVID‐19 = coronavirus disease 2019; ECMO = extracorporeal membrane oxygenation; HDU = high dependency unit; ICU = intensive care unit; NSW = New South Wales; NT = Northern Territory; NZ = New Zealand; QLD = Queensland; SA = South Australia; TAS = Tasmania; VIC = Victoria; WA = Western Australia. Box 2 – Number of ventilated (dark blue) and non‐ventilated (light blue) patients in Victorian intensive care units and the number of critical care staff unavailable to work due to coronavirus disease 2019 (COVID‐19) exposure or illness (green dots), listed each morning in the Critical Health Resources Information System (CHRIS) LOWESS = locally weighted scatterplot smoothing.

David Pilcher · Nicholas R Coatsworth · Melissa Rosenow · Jason McClure

An emergency imaging pathway based on local and international guidance tailored to the Australian health care setting Imaging in coronavirus disease 2019 (COVID‐19) is primarily helpful in diagnosing COVID‐19‐related complications and identifying alternative diagnoses that may explain a patient’s presentation. It can also be useful in the risk stratification of patients by identifying the presence and severity of comorbidities.1,2 Imaging is of limited use in screening for COVID‐19 in asymptomatic individuals, and in many cases where COVID‐19 symptoms are mild.1,3 Indiscriminate use of imaging in patients with confirmed or suspected COVID‐19 not only exposes the patient to unnecessary radiation but also represents an unnecessary infection risk and logistic demand for medical imaging departments. Existing international COVID‐19 imaging pathways have been derived in clinical environments significantly different from Australia, often where there is high COVID‐19 prevalence and constrained resource availability. Some centres preferentially use chest x‐ray, whereas others perform various types of computed tomography (CT) imaging of the chest. There is also inconsistency in the reporting of imaging studies in suspected or confirmed COVID‐19, with some reports following traditional didactic format, and others using synoptic template reports as recommended by a variety of medical bodies.4,5 Here we describe an imaging pathway developed at the Royal Adelaide Hospital, the designated COVID‐19 hospital in South Australia. This pathway aims to outline the imaging indications, technique and reporting of chest imaging in an emergency setting, at a time of low COVID‐19 prevalence. We incorporate current available international pathways and best practice guidelines for emergency imaging of COVID‐19 patients into a simple pathway relevant to Australian practice. Imaging pathway development We reviewed consensus and position statements from the Royal Australian and New Zealand College of Radiologists, the Australian and New Zealand Society of Thoracic Radiology, the Fleischner Society and the British Society of Thoracic Imaging. Recommendations pertaining to high COVID‐19 prevalence environments and resource‐constrained environments were modified to suit a scenario of low prevalence. When local guidelines conflicted with international organisations, priority was given to local recommendations on the basis of relevance. Recommendations were subsequently integrated into a clinical imaging pathway in consultation with local specialists in radiology, emergency medicine, general medicine, respiratory medicine and infectious diseases (Box). Reporting terminology The pathway incorporates standardised reporting terminology for patients with COVID‐19 as recommended by the Australian and New Zealand Society of Thoracic Radiology.5 Categorisation of study findings as “normal,” “indeterminate,” “typical” or “other diagnosis favoured” improves report clarity and creates actionable imaging outcomes. Appropriate use of CT The main role of CT in this pathway is to exclude complications and alternative diagnoses in patients with confirmed or suspected COVID‐19. The pathway prompts clinicians to consider CT for patients who are hypoxic (or have an oxygen requirement) and who have a chest x‐ray that is either “normal” or “indeterminate for COVID‐19”. In this instance there is a clinicoradiological discrepancy, and either a complication (such as a pulmonary embolus) or an alternative diagnosis is suspected. In keeping with British Society of Thoracic Imaging guidance, a low‐dose unenhanced CT of the chest is the CT scan of choice, with strong consideration given to an additional CT pulmonary angiogram.4 There is accumulating evidence that patients with COVID‐19 are abnormally prothrombotic, and conventional clinical decision rules and blood tests (especially D‐dimer) may not be applicable.3 Clinicians should have a lower threshold than usual for performing a CT pulmonary angiogram. The unenhanced CT functions primarily as a baseline, as the presence of intravenous contrast can artifactually simulate ground glass. Whenever possible, the non‐contrast CT scan and the CT pulmonary angiogram should be performed on the same occasion to minimise infection control risk and operational demands on medical imaging departments. Baseline imaging for patients at risk of deterioration Patients with comorbidities are recognised as being at higher risk of deterioration. Defined risk factors vary between institutions but include older patients, requirement for oxygen supplementation, significant comorbidities (especially cardiac or respiratory) and immunosuppression. The consensus statement from the Fleischner Society supports imaging in patients who have a positive test result for COVID‐19 and risk factors for disease progression, regardless of their clinical status. The use of imaging in this situation is to establish a baseline for future comparison and determine the extent of comorbidities. Imaging may also inform the intensity of follow‐up monitoring, either in the community or an inpatient setting.1 Incidental findings suspicious for COVID‐19 Although there are no radiological findings pathognomonic for COVID‐19, there are radiological findings commonly associated with infection.5 When imaging findings typical for COVID‐19 are seen in a patient who is not suspected of having infection, the pathway prompts the radiologist to discuss the findings with the referring emergency physician. Patient isolation and COVID‐19 testing may be required. This is intended as a safety net for patients who may not be identified by current clinical screening processes, acknowledging that patients with COVID‐19 may be asymptomatic, may present with atypical symptoms and do not necessarily have knowledge of close contact with an infected individual. Ultrasound There is some evidence that point‐of‐care ultrasound can be used in the imaging of patients with COVID‐19; however, given variability in specialist expertise and availability, this has not been incorporated in this pathway.1 Conclusion Chest imaging in suspected or confirmed COVID‐19 in a low prevalence environment is best used to detect complications and rule out alternative diagnoses. The pathway described here aims to clarify imaging indications, technique and reporting of studies performed on patients with suspected or confirmed COVID‐19 in an acute care setting. Box – COVID‐19 emergency imaging guidelines AP = anteroposterior; ANZSTR = Australian and New Zealand Society of Thoracic Radiology; COVID‐19 and COVID = coronavirus disease 2019; CT = computed tomography; CTPA = computed tomography pulmonary angiogram; CXR = chest x‐ray; ED = emergency department.

David Ngan · Suzanne McKeen · Meegan Gun · Daniel Haustead · Andrew Low · Brett Lorraine · James Bewes

Putting in place the mechanisms to assess coverage in vulnerable groups is essential to drive optimal uptake and best practice Several targeted vaccine programs introduced to the Australian National Immunisation Program (NIP) in 2020 exposed the limitations of the Australian Immunisation Register (AIR), particularly, its inability to collect information on medical risk factors to monitor vaccine uptake in at‐risk groups. These program changes highlight the need to optimise AIR reporting to improve the accuracy of individual‐level vaccination data for the benefit of patients and treating clinicians as well as the ongoing surveillance of vaccine coverage for medically at‐risk groups. As of 1 July 2020, Bexsero (GSK), the meningococcal B vaccine, was funded by the NIP for all Aboriginal and Torres Strait Islander children aged under 2 years and for other populations with specific medical risk factors, including asplenia, hyposplenia, complement deficiency, and use of eculizumab therapy.1 Additional doses of the pneumococcal 13‐valent conjugate vaccine (Prevenar 13, Pfizer) and the 23‐valent pneumococcal polysaccharide vaccine (Pneumovax 23, MSD) are now funded for Aboriginal and Torres Strait Islander people and for individuals with certain medical risk factors (eg, asplenia, immunosuppressive conditions, specific respiratory disorders).2 While these NIP changes are welcomed, clinicians need access to data that include information on medical risk to optimise benefits to patients. Both patients and medical practitioners need capacity to track receipt, ensuring that the most vulnerable people receive the recommended vaccines, and avoid unnecessary repeat vaccinations. Assessing compliance with these policy changes will be difficult because medically at‐risk individuals are currently unable to be identified on the AIR. The functionality of the AIR needs to change to enable the collection of medical risk factors, including pregnancy, and strive for more complete reporting of vaccinations that will deliver benefits at both a population and individual level. Accurate coverage data are vital for clinicians to be able to offer evidence‐based care and ensure their most vulnerable patients are protected, and to inform strategies to improve vaccine uptake. Globally, the strongest predictor of influenza vaccine receipt in pregnant women and children with medical comorbidities is a health care provider recommendation.3,4,5 Facilitating health care provider recommendations and other effective strategies to improve uptake, such as reminders or prompts for clinicians or text messages from clinicians to patients, will not be optimal without accurate vaccination data. In this article, we aim to highlight the need for optimising reporting to the AIR and increasing its capacity to collect information on medical risk factors, ensuring maximum program reach of targeted programs, and propose potential solutions. Lower uptake of targeted vaccine programs Despite targeted vaccine programs aiming to improve coverage for vulnerable groups, they often have lower uptake than universal vaccine programs.3,4,6,7,8 With the exception of Aboriginal and Torres Strait Islander people, the AIR currently fails to recognise people who qualify as vulnerable because the AIR does not capture “at‐risk” status, rendering the eligible group (ie, denominator) not easy to identify. Before 2016, the Australian Childhood Immunisation Register only recorded childhood vaccines up to 7 years. With the expansion to the whole‐of‐life AIR in September 2016, it was hoped that adult vaccinations, including maternal influenza and pertussis vaccines for pregnant women and vaccines for medically at‐risk groups, would be captured. This is an ongoing priority because the uptake of maternal influenza vaccine remains suboptimal, estimated to be 39% in Victoria between 2015 and 2017,6 with variation nationally across years and jurisdictions — 31.7% (Northern Territory, 2016), 54% (New South Wales, 2016) and 76% (South Australia, 2017).8,9,10 Similarly, influenza vaccine uptake in medically at‐risk children also remains suboptimal (about 40% nationally for 2014–2015 and 2017).3,4 Lack of recording of at‐risk status At present, there is no capacity to link vaccine receipt on the AIR with a person’s at‐risk status, as the register lacks the functionality to do so. There is a need for the AIR to be able to more accurately track vaccine receipt nationally to identify strategies to improve coverage in at‐risk groups. The lack of pregnancy status capture in the AIR necessitates the use of other data sources, such as perinatal datasets in jurisdictions where maternal immunisation is collected, or population surveys to obtain coverage estimates, but these are of no use to clinicians at the individual level. This is also the case for children who are medically at‐risk, with no capacity to link medical risk factors with vaccine receipt for identification and tracking of these children. Parents are known to over‐report vaccination status, particularly for children with complex and ongoing medical conditions.11 Identification of at‐risk status would also enable more targeted estimates of vaccine effectiveness for at‐risk individuals, rather than extrapolating from population‐level data, enabling more comprehensive assessment of targeted vaccine programs. Aside from the few countries that link national or statewide immunisation registers to health data,12 evaluating the uptake of influenza vaccination in medically at‐risk groups is a global problem, with considerable gaps in monitoring coverage due to incomplete identification of these individuals. Requirement to report vaccines to the AIR Until recently, while strongly encouraged, there was no requirement to report vaccinations to the AIR except for pharmacists under legislation in NSW and the Australian Capital Territory.13 However, an amendment to the AIR Act has recently been legislated, making it mandatory for all vaccination providers to report to the AIR vaccines given under the NIP, through school‐based programs and privately, such as for seasonal influenza and vaccines required for travel purposes.14 Under the new legislation, coronavirus disease 2019 (COVID‐19) vaccines must be reported to the AIR. In addition, influenza vaccinations must be reported to the AIR from 1 March 2021 and all other NIP vaccinations must be reported from 1 July 2021.15 The requirement has ramifications, as the completeness of reporting is likely to be lower for vaccines recommended and funded as part of targeted programs on the NIP, previously limiting accurate coverage assessments. While no studies have examined completeness of reporting maternal vaccination to the AIR,6,7 this is exacerbated by incomplete adult vaccination data in the register, especially with the expansion of other vaccine providers, such as pharmacists and workplace programs.16 The COVID‐19 pandemic highlights the requirement for a more adaptable AIR. With more than 200 COVID‐19 vaccine candidates in development,17 the rollout of COVID‐19 vaccines will be complex due to expected availability and the delivery capacity of immunisation providers. With a need to protect the most vulnerable people first, Australia’s COVID‐19 vaccination program will prioritise border and quarantine staff, health care workers and medically at‐risk groups. These vaccination encounters will need to be recorded and tracked, both for coverage and vaccine safety, using active surveillance systems such as AusVaxSafety (www.ausvaxsafety.org.au). Potential solutions to improve vaccine uptake and tracking Improving vaccine uptake in targeted programs requires a multifaceted approach, such as education, reduction of access barriers, and key structural modifications that should focus on core capabilities of the AIR and reporting requirements. While recent NIP changes present a unique opportunity to redefine the core functions of the AIR, there are potential complexities and ethical considerations around reporting pregnancy and medical conditions to the register. One potential solution would be to consider the linkage of AIR data to other national datasets (eg, Medicare, the Pharmaceutical Benefits Scheme, hospitalisations, the Therapeutic Goods Administration adverse event database), as occurs in some other countries.12 This is relevant for the introduction of COVID‐19 vaccines, for which safety monitoring and coverage tracking will be critical. Another solution would be to include pregnancy and medical risk factor data fields in the AIR. This information could be entered directly by providers if reporting on the AIR secure website or reported in a semi‐automated manner via practice management software (PMS), which is how most reporting currently occurs. While pregnancy and medical risk factors are often recorded in PMS, ensuring this is done routinely and updated appropriately would require substantial provider education. To improve access and ensure better integration within immunisation provider settings, particularly in general practice, bidirectional capacity could be developed to enable the AIR to link with PMS to reconcile vaccination status and provide clinical decision support on catch‐up vaccination schedules. The stricter reporting requirements, such as mandated reporting of all vaccinations and linking NIP vaccines with reporting, as outlined in the recent Australian Immunisation Register Amendment (Reporting) Bill 2020,14 will be beneficial, although the implementation and ensuring compliance may be challenging. Under the new AIR Reporting Bill, in addition to education and support, non‐compliant providers may also be subject to financial penalties. However, an incentives approach to reporting, in addition to mandated reporting, could also be implemented. For example, general practitioners and other immunisation providers could receive administrative payments for reporting vaccinations to the AIR (similar to what is done with the NIP childhood vaccines), thus acknowledging the time it takes from their busy schedule. Despite the AIR being internationally recognised and celebrated within Australia, there is opportunity for improvement if the AIR is to fulfil its potential as a lifelong register. The most pressing challenges ahead are the need to continue to optimise reporting to the AIR and build capacity to identify special risk groups (particularly given the new targeted NIP programs), and the need to improve reporting of all non‐NIP vaccines. We welcome the recent AIR Reporting Bill 2020; however, there remains a particularly urgent need to have the ability to identify individuals with risk factors such as pregnancy or medically at‐risk status. This would not only use the full potential of the AIR and optimise vaccine coverage surveillance but would also offer benefits at the individual level. We appreciate that such changes to the AIR and provider practice may be cumbersome. However, we are seeking support from the broader medical community to raise awareness and advocate that these changes should be prioritised, not only to improve accuracy in recording of vaccinations and at‐risk status but also to facilitate providers’ ability to access AIR data for better patient care. NIP vaccine programs tailored to the increased risk experienced by population groups are important, such as those targeted to pregnant women or medically at‐risk individuals. We must ensure that we have the mechanisms to accurately assess coverage in these vulnerable groups, not just the routine childhood NIP‐funded groups, to drive optimal uptake and best practice.

Jane Tuckerman · Christopher C Blyth · Frank H Beard · Margie H Danchin

Careful planning is required to deliver a safe and effective COVID‐19 program Providing a safe and effective coronavirus disease 2019 (COVID‐19) vaccination program is required to mitigate against the current and future negative impacts on the health and wellbeing of all Australians from COVID‐19. An effective vaccination program is a key element required to facilitate economic recovery, safe movement throughout and beyond Australia and a return to the quality of life previously experienced. Development of COVID‐19 vaccines has progressed with incredible speed. Results of phase 3 studies were released in December,1,2,3 11 months after the pandemic was identified. Progress towards a COVID‐19 vaccine program has occurred at pace. Developing a COVID‐19 vaccine program With over 60 candidates in clinical trials, unprecedented efforts are driving vaccine development. Numerous approaches to vaccine design have been utilised, including traditional (inactivated, live attenuated, protein subunit) and more novel approaches (viral vector, nucleic acid). COVID‐19 vaccination program development and registration have progressed in Australia through well established existing pathways and partnerships. The National Immunisation Program was established by the Commonwealth, state and territory governments in 1997 to provide funded vaccines to the Australian population. Partnerships that underpin this program are being used to develop the COVID‐19 vaccination program. Vaccines are assessed through the national therapeutics regulator, the Therapeutic Goods Administration (TGA), which assesses safety, quality and efficacy, with advice from an independent body of experts, the Advisory Committee on Vaccines (Box). The Australian Technical Advisory Group on Immunisation (ATAGI) provides technical and clinical advice on the role of vaccines on the National Immunisation Program and oversees development of the Australian Immunisation Handbook. These existing organisations and committees are being utilised for developing the COVID‐19 vaccine program. Funding of vaccines on the National Immunisation Program usually requires submission to the Pharmaceutical Benefits Advisory Committee. If it is deemed cost‐effective, the Pharmaceutical Benefit Advisory Committee provides a recommendation to government for funding. Given the need for rapid action, the Australian Government established the COVID‐19 Vaccine Taskforce. Potential vaccines are being assessed by government, with advice from the COVID‐19 Vaccine and Treatments for Australia – Science and Industry Technical Advisory Group.4 Ensuring rapid access to COVID‐19 vaccines, the Australian Government secured agreements with suppliers of four lead candidates. A commitment to provide free access to vaccine for all people in Australia has been made.5 Leading vaccine candidates Considering different modes of action and the need for a range of suppliers with international and local manufacturing potential, advanced purchase agreements were signed in 2020 for the University of Oxford–AstraZeneca ChAdOx‐1 nCoV‐19 (AZD1222) vaccine (a viral vector vaccine); the University of Queensland–CSL V451 and Novavax NCX‐CoV2373 vaccines (protein subunit vaccines); and the Pfizer–BioNTech BNT162b2 vaccine (an mRNA vaccine).6 Interim phase 3 results have been published for two of these vaccines. Following randomisation of > 43 000 individuals aged ≥ 16 years (predominantly in the United States) receiving two doses of BNT162b2 or placebo, a 95% reduction in symptomatic laboratory‐confirmed COVID‐19 was reported among vaccine recipients (95% credible interval, 90.3–97.6%).2 Over 23 000 individuals aged ≥ 18 years were randomised into studies conducted in the United Kingdom, Brazil and South Africa. Randomised individuals received two doses of either AZD1222 (albeit utilising different dosing schedules) or a meningococcal vaccine; a 70.4% (95.8% CI, 54.8–80.6%) reduction in symptomatic laboratory‐confirmed COVID‐19 was observed.3 Further results from these trials are anticipated in 2021. Results from a phase 3 study of NCX‐CoV2373 involving more than 15 000 enrolled individuals aged ≥ 18 years were provided (by media release) in January 2021. The first interim analyses reported vaccine efficacy against symptomatic COVID‐19 infection of 89.3% (95% CI, 75.2–95.4%).7 V451, which uses the human immunodeficiency virus (HIV) gp41 protein to maintain the severe acute respiratory syndrome coronavirus 2 spike protein in its pre‐fusion state, generated false positive HIV antibody test results in vaccine recipients in phase I trials. Given potential adverse impacts on the program and the need to modify HIV testing algorithms, further trials of this vaccine were abandoned, with CSL agreeing to increase local manufacturing of AZD1222.8 Of the leading contenders, Australia has secured access to 20 million doses of BNT162b2 and 3.8 million doses of internationally manufactured AZD1222, with CSL also committed to locally manufacture 50 million doses of the latter.7 Much of the global 2021 vaccine manufacturing capacity is tied to pre‐market purchasing commitments, with Australia a leader in terms of the number of courses available per capita and diversity of vaccines.9 In addition, the Australian Government has joined 188 countries in providing funding to the COVID‐19 Vaccines Global Access (COVAX) Facility,10 a key pillar of the World Health Organization (WHO) Access to COVID‐19 Tools Accelerator.11 This enables access to a range of additional candidates but also supports access to vaccines for low to middle income countries. A critical question is the relative efficacy and real‐world effectiveness of current vaccines being trialled. No comparative trials are underway. Despite differences in efficacy point estimates, differences in trial design and study populations preclude any conclusions about their relative impact. For Australians, successful phase 3 studies show that both BNT162b2 and AZD1222 are likely to be effective. Both vaccines are likely to have key roles in the Australian program. Encouraging results from other candidates, including NCX‐CoV2373, suggest that these vaccines may also play a role. Key steps Essential components of the national COVID‐19 vaccine strategy12 include: identifying and supporting research and development; building a diverse portfolio of investments and strengthening local manufacturing; fostering international partnerships to contribute to the global efforts; streamlining regulatory pathways13 and collaborating with international regulators; and working with the ATAGI COVID‐19 Working Group14 to develop a safe and effective vaccination program. Potential candidates have been reviewed in detail by the TGA and ATAGI, a process which will continue as further data emerge. Provisional determination by the TGA for potential vaccines enables preliminary data to be reviewed ahead of submission of the full regulatory dossier.13 Full review of lead candidates by the TGA led to approval of both Pfizer–BioNTech BNT162b2 and Oxford–AstraZeneca AZD1222. Ongoing review of other candidates continues. Advice on priority populations continues to be developed by ATAGI, initially focusing on population groups at greatest risk of exposure, severe outcomes and transmission, in addition to individuals critical to societal functioning such as emergency services, police and public health personnel.15 Key values (as outlined in the WHO Strategic Advisory Group of Experts on Immunisation values framework) including wellbeing, respect, equity, reciprocity and legitimacy have been considered in identifying priority populations.16 Prioritisation must be informed by both the epidemiology (with a focus on locations with current community COVID‐19 activity) and modelling to examine the impact of varying vaccine characteristics (relative effectiveness, duration of protection) and target populations on overall disease control. Health care and aged care workers have been identified as priority groups for early vaccination in all scenarios. In addition to sites of routine immunisation delivery, additional locations including dedicated vaccination clinics and workplace and in‐reach clinics will be required to ensure timely access for all.17 Chosen locations will need to consider logistic challenges including storage conditions (the Pfizer–BioNTech vaccine must be stored at − 60⁰C to − 90⁰C and used within 5 days of defrosting)18 and supply in multi‐vial trays containing multi‐use vials. Workforce development, training and resources (particularly in the safe use of different multi‐use vials) are critical components required for a safe and successful program. Current COVID‐19 vaccine trials include 30 000–50 000 participants, of whom roughly half will receive the vaccine. These large studies can detect common adverse events, but to pick up serious but very rare side effects, ongoing monitoring of vaccine safety will be required. Post‐marketing surveillance, underway in the Northern Hemisphere, will provide additional reassurance about the safety of these vaccines. A COVID‐19 pharmacovigilance plan, incorporating key vaccine safety programs developed since 2009 including AusVaxSafety (http://www.ausvaxsafety.org.au) and vaccine safety reporting programs established in states and territories, will ensure real‐time monitoring of adverse events. Critical to safety and effectiveness monitoring is use of the Australian Immunisation Register. Amendments to the Australian Immunisation Register legislation requiring mandatory reporting of all vaccines have been passed by Federal Parliament.19 Additional data systems to streamline reporting to the Australian Immunisation Register and provider education will be required to ensure all administered doses are captured. These changes will ensure all individuals have a valid, durable and reliable record of vaccination. This will assist program rollout (eg, being able to determine which brand a patient has previously received) and also help inform program evaluation (eg, by providing estimates of vaccine coverage at the population level). Provider and community confidence are paramount to program success.20 Ongoing research to explore the structural, social and behavioural factors that may compromise vaccine acceptance is required. Clear and regular communication with providers and the public by trusted scientific and public health sources about what is known, as well as uncertainties, is required. The development and dissemination of evidence‐based information, along with additional messages for specific target groups and support materials to assist health care providers in discussions with patients, continue to be prepared. A clear and realistic understanding of vaccine effectiveness and expected adverse events are required to combat an anticipated escalation in COVID‐19 vaccine misinformation. As we commence the COVID‐19 vaccination program, we enter a new phase of the Australian response to the pandemic. Although millions of influenza vaccines are distributed each year, the COVID‐19 immunisation program will be more complex than any other immunisation program in Australia’s history. Evidence‐informed public policy, collaboration between governments and between program administrators and providers, along with clear communication, are required to ensure programmatic success. Box – Key steps involved in routine and COVID‐19 immunisation programs Routine immunisation delivered by the National Immunisation Program COVID‐19 immunisation program Initiation of process Sponsor application to the TGA and PBAC Australian Government with advice from the SITAG Regulatory decisions TGA with advice from the ACV TGA with advice from the ACV Purchasing decisions Australian Government with advice from the PBAC Australian Government with advice from the SITAG Clinical and other technical information Statements from ATAGI with support from the NCIRS Multiple providers, including ATAGI statements, NCIRS fact sheets and training materials contracted by Australian Government Department of Health Program implementation Australian Government Department of Health in conjunction with jurisdictions Australian Government COVID‐19 Vaccine Taskforce and Department of Health in conjunction with jurisdictions ACV = Advisory Committee on Vaccines; ATAGI = Australian Technical Advisory Group on Immunisation; NCIRS = Immunisation Research and Surveillance; PBAC = Pharmaceutical Benefits Advisory Committee; SITAG = COVID‐19 Vaccines and Treatments for Australia – Science and Industry Technical Advisory Group; TGA = Therapeutic Goods Administration.

Christopher C Blyth · Katie L Flanagan · Robyn A Gibbs · Nigel W Crawford · Allen C Cheng